The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mereo BioPharma
• Treatments: Acumapimod; Azithromycin

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.