The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

An Open-label, Single-sequence Study to Evaluate the Effect of Azithromycin on BCT197 Exposure in Healthy Male Subjects

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

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.

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.