The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

Mereo BioPharma

Status and phase

Completed

Phase 1

Conditions

Interaction

Treatments

Drug: BCT197

Drug: Azithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02926326

MBCT102

Details and patient eligibility

About

An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.

Full description

This will be an open study conducted in healthy male subjects at a single centre. Each subject will participate in a screening visit and 2 study periods. At the first study period, all subjects will receive a single dose of BCT197 and at study period 2, all subjects will receive 3 daily doses of azithromycin and a single dose of BCT197.

Enrollment

16 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Healthy male subjects.
Non-smokers (including e-cigarettes).
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
Willing to use highly effective barrier contraception methods.
Male subjects must not donate sperm during the study.

Exclusion Criteria

Any subjects with pre-existing active skin disease.
Laboratory values at screening which are deemed to be clinically significant.
Volunteers with abnormal liver function tests.
12 Lead ECG with QTcF >450 msec.
Allergy to any of BCT197 excipients.
Known hypersensitivity or intolerance to azithromycin.
Taking medications known to cause QTc prolongation.
Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
Any clinically significant illness within 30 days prior to study drug administration.
Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.