Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

Study Overview
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Brief Summary
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This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.

Conditions
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Alopecia, Alopecia, Androgenetic, Baldness

Intervention / Treatment
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* Drug: bimatoprost Formulation A
* Drug: bimatoprost Formulation B
* Drug: bimatoprost Formulation C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males with moderate male-pattern baldness (androgenic alopecia) Females with moderate female pattern hair loss Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products Exclusion Criteria: Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females) Use of bimatoprost or other prostaglandin analogs within 3 months Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months Any prior hair growth procedures (eg, hair transplant or laser) Blood donation or equivalent blood loss within 90 days History of alcohol or drug addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: bimatoprost Formulation A<br>bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. | Drug: bimatoprost Formulation A<br>* bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.<br>|
| Experimental: Part 1: bimatoprost Formulation B<br>bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. | Drug: bimatoprost Formulation B<br>* bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.<br>|
| Experimental: Part 2: bimatoprost Formulation C<br>bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. | Drug: bimatoprost Formulation C<br>* bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. | Day 1 | 
| Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended. | 17 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm. | 17 Days | 
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms. | Baseline, 20 Days | 
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms. | Baseline, 20 Days |