NCT02250859

A Pharmacokinetic Study of Minocycline in Male and Female Volunteers

An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne

Detailed description

This is an open-label, single-center, non-randomized, multiple-administrations study in males and females, some of which are with acne. Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days. Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne). On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	FMX101, Minocycline 4% foam	FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2014-09-26
• Last updated: 2021-02-25

Locations

1 site across 1 country: Israel