International Phase III, Multi Center, Randomized, Double Blind, Placebo and Active Controlled and Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female Patients With Androgenetic Alopecia

The goal of this clinical trial is to learn about oral minoxidil 1mg in the treatment of women with androgenetic alopecia, a type of hormone-imbalanced hair loss.
The main questions to answer are to know about that minoxidil 1mg is as effective as minoxidil 2% topical solution (comparator product) and is more effective than placebo; and to ensure treatment with oral minoxidil is safe.
Participants will be assigned randomly to receive one of the following treatment combinations:
the test product (oral minoxidil 1 mg, once/day) and the vehicle solution (vehicle means it looks like the comparator product, but it does not contain an active ingredient, 2 times/day), or
the placebo tablet (placebo means it looks like the test product, but it does not contain an active ingredient, once/day) and the comparator product (2% minoxidil solution, 2 times/day), or
the placebo tablet (once/day) and the vehicle solution (2 times/day).
The clinical trial will take up to 36 weeks. During this time, patients will come to the clinical trial centre for 5 times for examinations and will be called by phone twice. At the visits, the following examinations will be performed: photos of the hair will be taken to determine hair density, assessment of changes in scalp hair growth, measurement of blood pressure, pulse, and body temperature, a physical examination, blood withdrawal to determine any abnormalities in the blood, urine sampling and analysis, performance of ECG, and evaluation of hypertrichosis (i.e., excessive hair growth over the body). Furthermore, patients will be asked daily whether they had experienced any side effects or took any new medications (or changed the dose of a known medication) or underwent any medical procedure. Also, women of childbearing potential must undergo pregnancy tests in blood and urine.

Start Date01 Jun 2024

Sponsor / Collaborator

Industrial Farmaceutica Cantabria SA

[+2]

CTRI/2024/02/063225 / Not yet recruitingNot Applicable

Comparison of efficacy of topical 0.025 % Dutasteride plus 5 % Minoxidil solution vs topical Minoxidil 5 % alone in male androgenetic alopecia - a randomised open label pilot study - NIL

Start Date02 Mar 2024

Sponsor / Collaborator-

NCT06015516 / Enrolling by invitationPhase 1

Randomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.

The goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of the drug in the body) of a new oral formulation of minoxidil administered in healthy volunteers.
The main question that is to answer is to evaluate the bioavailability of the oral test formulation of minoxidil. The secondary onjectives is to compare it with the formulation already on the market (i.e . Regaxidil® 20 mg/mL cutaneous solution).
It is planned that 14 healthy female volunteers of legal age (without any known pathology) participate in the study. The expected duration of the study is approximately 23-56 days.
Each volunteer that decide to participate in this study will be sequentially administered one of the formulations planned for the study: either the test formulation (oral minoxidil tablets of 1 mg, developed by Industrial Farmacéutica Cantabria, S.A.), or the reference formulation (minoxidil skin solution, 20 mg/mL, marketed by Industrial Farmacéutica Cantabria, S.A.). After five days of administration of one of the study formulations, at least 7 days will elapse before starting an additional five days of administration of the other study formulation that had not been administered in the first sequence. Assignment to this sequence of administration of the study formulations (oral formulation or topical solution) shall be completely randomised.
In each of these sequential periods of five days of administration of the study formulations, the concentration of minoxidil will be quantified in blood samples, which will be taken from each of the volunteers at certain times after the administration of the medication. These blood analyses will enable to determine the parameters that define the pharmacokinetic profile of the new oral formulation under study.

Start Date09 Feb 2024

Sponsor / Collaborator

Industrial Farmaceutica Cantabria SA

100 Clinical Results associated with SUR1

100 Translational Medicine associated with SUR1

0 Patents (Medical) associated with SUR1

1,915

Literatures (Medical) associated with SUR1

17 Feb 2024·Diabetologia

A loss-of-function mutation in KCNJ11 causing sulfonylurea-sensitive diabetes in early adult life.

Article

Author: Natascia Vedovato ; Maria V Salguero ; Siri Atma W Greeley ; Christine H Yu ; Louis H Philipson ; Frances M Ashcroft

AIMS/HYPOTHESIS:

The ATP-sensitive potassium (K_ATP) channel couples beta cell electrical activity to glucose-stimulated insulin secretion. Loss-of-function mutations in either the pore-forming (inwardly rectifying potassium channel 6.2 [Kir6.2], encoded by KCNJ11) or regulatory (sulfonylurea receptor 1, encoded by ABCC8) subunits result in congenital hyperinsulinism, whereas gain-of-function mutations cause neonatal diabetes. Here, we report a novel loss-of-function mutation (Ser118Leu) in the pore helix of Kir6.2 paradoxically associated with sulfonylurea-sensitive diabetes that presents in early adult life.

METHODS:

A 31-year-old woman was diagnosed with mild hyperglycaemia during an employee screen. After three pregnancies, during which she was diagnosed with gestational diabetes, the patient continued to show elevated blood glucose and was treated with glibenclamide (known as glyburide in the USA and Canada) and metformin. Genetic testing identified a heterozygous mutation (S118L) in the KCNJ11 gene. Neither parent was known to have diabetes. We investigated the functional properties and membrane trafficking of mutant and wild-type K_ATP channels in Xenopus oocytes and in HEK-293T cells, using patch-clamp, two-electrode voltage-clamp and surface expression assays.

RESULTS:

Functional analysis showed no changes in the ATP sensitivity or metabolic regulation of the mutant channel. However, the Kir6.2-S118L mutation impaired surface expression of the K_ATP channel by 40%, categorising this as a loss-of-function mutation.

CONCLUSIONS/INTERPRETATION:

Our data support the increasing evidence that individuals with mild loss-of-function K_ATP channel mutations may develop insulin deficiency in early adulthood and even frank diabetes in middle age. In this case, the patient may have had hyperinsulinism that escaped detection in early life. Our results support the importance of functional analysis of K_ATP channel mutations in cases of atypical diabetes.

16 Feb 2024·Analytical chemistry

Unfolded Protein-Based Sandwich AIE Probe Imparts High Fluorescent Contrast for Pan-Cancer Surgical Navigation.

Article

Author: Quan Wang ; Biao Chen ; Chong Duan ; Tingting Wang ; Xiaoding Lou ; Jun Dai ; Fan Xia

Fluorescence imaging-guided navigation for cancer surgery has a promising clinical application. However, pan-cancer encompasses a wide variety of cancer types with significant heterogeneity, resulting in the lack of universal and highly contrasted fluorescent probes for surgical navigation. Here, we developed an aggregation-induced emission (AIE) probe (MI-AIE-TsG, MAT) with dual activation for pan-cancer surgical navigation. MAT weakly activates fluorescence by targeting the SUR1 protein on the endoplasmic reticulum (ER) through the TsG group. Subsequently, the sulfhydryl groups on the unfolded proteins, which are highly enriched in cancer ER, react with the maleimide (MI) of MAT through the thiol-ene click reaction, further enhancing the fluorescence. The formation of a SUR1-MAT-unfolded protein sandwich complex reinforces the restriction of intramolecular motion and eliminates photoinduced electron transfer of MAT, leading to high signal-to-noise (9.2) fluorescence imaging and use for surgical navigation of pan-cancer. The generally high content of unfolded proteins in cancer cells makes MAT imaging generalizable, and it currently has proven feasibility in ovarian, cervical, and breast cancers. Meanwhile, MAT promotes cellular autophagy by hindering protein folding, thereby inhibiting cancer cell proliferation. This generalizable, high-contrast AIE fluorescent probe spans the heterogeneity of pancreatic cancer, enabling precise pancreatic cancer surgery navigation and treatment.

01 Feb 2024·The CRISPR journal

Generation of Human Isogenic Induced Pluripotent Stem Cell Lines with CRISPR Prime Editing.

Article

Author: Lori L Bonnycastle ; Amy J Swift ; Erin C Mansell ; Angela Lee ; Elizabeth Winnicki ; Elizabeth S Li ; Catherine C Robertson ; Victoria A Parsons ; Trung Huynh ; Chad Krilow ; Karen L Mohlke ; Michael R Erdos ; Narisu Narisu ; Francis S Collins

We developed an efficient CRISPR prime editing protocol and generated isogenic-induced pluripotent stem cell (iPSC) lines carrying heterozygous or homozygous alleles for putatively causal single nucleotide variants at six type 2 diabetes loci (ABCC8, MTNR1B, TCF7L2, HNF4A, CAMK1D, and GCK). Our two-step sequence-based approach to first identify transfected cell pools with the highest fraction of edited cells significantly reduced the downstream efforts to isolate single clones of edited cells. We found that prime editing can make targeted genetic changes in iPSC and optimization of system components and guide RNA designs that were critical to achieve acceptable efficiency. Systems utilizing PEmax, epegRNA modifications, and MLH1dn provided significant benefit, producing editing efficiencies of 36-73%. Editing success and pegRNA design optimization required for each variant differed depending on the sequence at the target site. With attention to design, prime editing is a promising approach to generate isogenic iPSC lines, enabling the study of specific genetic changes in a common genetic background.

News (Medical) associated with SUR1

06 Oct 2022

·www.prnewswire.com

Chuck Noll Foundation for Brain Injury Research announces new grants supporting critical brain injury research

Expands reach beyond Pittsburgh; exceeds $2 Million awarded since Inception PITTSBURGH, Oct. 6, 2022 /PRNewswire/ -- The Chuck Noll Foundation for Brain Injury Research has announced $452,000 in new grants that have been awarded to support brain injury research. The foundation, which provides early-stage research grants to improve the diagnosis, treatment, and prevention of brain injuries primarily from sports, has now funded 18 research projects, providing more than $2 million in early stage grants since 2016. Continue Reading "With a focus on research, related to diagnosis and treatment, we are excited about the potential this round of grants has to impact the lives of people who face brain injuries," said Chairman Arthur J. Rooney, II, President of the Pittsburgh Steelers and Chairman of the Foundation Board. "With each cycle, researchers are given the opportunity to break scientific boundaries in brain injury research and we're grateful to our supporters for their commitment." "Funding for pilot studies is highly coveted...emerging investigations have immense potential..." Tweet this This cycle marks the first in which the organization has provided grants beyond its headquarters of Pittsburgh, expanding its reach nationally. "Funding for pilot studies is highly coveted and remains limited but emerging investigations have immense potential to impact our understanding of an individual's brain," said Dr. Nitin Agarwal formerly at the University of Pittsburgh Medical Center now with the Washington University School of Medicine. This research project is focused on developing a non-invasive imaging biomarker that can identify optimal treatments and predict better outcomes for people with brain injuries. This type of research depends on a foundation like The Chuck Noll Foundation, which has a unique and distinct focus on early stage research. This work has enormous potential to impact people with injuries and is delivering exciting results. The Chuck Noll Foundation opened its call for proposals beyond Pittsburgh for the first time in the spring of 2022. "Anywhere between 1.7 and 3 million people are impacted by sports-related brain injuries annually in our country. This is why the interest in our work has been strong and important." explained John Denny, executive director. "As we work to diminish the impact of sports-related head injuries, our latest cycle attracted research proposals from across the nation as well as internationally. Beyond our direct grants, our research projects have led to the leveraging of an additional $12 million, creating a ripple effect of impact." "Due to the quality, the success and the multiplier effect of our grants, we have now expanded requests for proposals nationally," said Dr. Joseph C. Maroon, Chair of the foundation's National Science Advisory Committee. The new research grants include: Institution: Washington University School of Medicine Title: "Identifying occult traumatic brain injury in professional athletes using a novel non-invasive biomarker" Researcher: Nitin Agarwal Amount: $125,000 Institution: University of Pittsburgh and Barrow Neurological Institute Title: "Sulfonylurea Receptor-1 and Glyburide: A Single-Cell Precision Medicine Approach to Preventing Brain Swelling and Providing Neuroprotection for the Second Impact Syndrome" Researchers: Patrick M. Kochanek and Ruchira M. Jha, Principal Investigators Amount: $125,000 Institution: UPMC, University of Pittsburgh Title: "Impact of obesity on blood-based biomarkers and recovery trajectories following mild traumatic brain injury" Researchers: Shawn R. Eagle and David O. Okonkwo Amount: $125,000 Institution: The Pennsylvania State University Title: "Examining the link between finite element-based strain predictions and cognitive changes." Researcher: Reuben Kraft, Principal Investigator Amount: $77,589 Prior grantees include Allegheny General Health, Carnegie Mellon University and the University of Pennsylvania. For more information on the specific grants or the organization, go to: About the Chuck Noll Foundation for Brain Injury Research: Established in 2016 through a grant from the Pittsburgh Steelers, The Chuck Noll Foundation for Brain Injury Research was established to diminish the impact of sports related head injuries. The organization provides early stage research grants to improve the diagnosis, treatment, and prevention of brain injuries that include more than $2 million in early stage grants since its inception, spurred by an additional $12 million from other sources. Noll enjoyed a 23-year coaching career with the Steelers and held a deep commitment to the well-being of his players, which led to the development of the ImPACT test (Immediate Post-Concussion Assessment and Cognitive Testing). Since 2007, this test has become a model used by NFL team doctors, and now internationally, to help monitor concussions for athletes at all levels. For more information: Contact: Anna Havrilla [email protected] (412) 913-3343 SOURCE Chuck Noll Foundation for Brain Injury Research

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SUR1

Sulfonylurea receptor 1

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