Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05864885|
Recruitment Status : Not yet recruiting
First Posted : May 18, 2023
Last Update Posted : May 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Drug: Minoxidil||Phase 1|
At screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. Screening data will include demographics, medical history, concomitant medications, physical examination, weight, O2 sat, vital signs laboratory evaluation (CMP, CBC, UA), and ECG.
At Day 1, a physical exam, weight, O2 sat, vital signs (including BP, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed.
If criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). If there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). The study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for Study Days 1, 2, 3, 4, 5, 6, and 7. Daily subject visits will include vital signs, review of adverse events and concomitant medications. PK draws and ECGs will take place at Study Days 1, 2, 7 and 8, following the first dose and the last doses, respectively.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Safety and Pharmacokinetics of Once-Daily Topical Solution in Male Subjects With Androgenetic Alopecia|
|Estimated Study Start Date :||June 9, 2023|
|Estimated Primary Completion Date :||July 17, 2023|
|Estimated Study Completion Date :||July 17, 2023|
Experimental: Primary safety and pharmacokinetic data
To obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp
Topical formulation applied once a day.
Other Name: Latanoprost
- Pharmacokinetic data: Cmax [ Time Frame: 7 days ]Individual and mean maximum plasma concentration (Cmax)
- Pharmacokinetic data: tmax [ Time Frame: 7 days ]Individual and mean tmax
- Pharmacokinetic data: Half-life (t1/2) [ Time Frame: 7 days ]Individual and mean half-life (t1/2)
- Pharmacokinetic data: AUC [ Time Frame: 7 days ]Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
- Pharmacokinetic data: Drug clearance [ Time Frame: 7 days ]Individual and mean apparent clearance of drug from plasma
- Safety : Skin TEAEs [ Time Frame: 7 days ]Incidence of treatment-emergent adverse events related to skin irritation at the administration site
- Safety: Systemic TEAEs [ Time Frame: 7 days ]Incident of systemic treatment-emergent adverse events
- Safety: Evaluation of QTs Interval Prolongation [ Time Frame: 7 days ]Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed