The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

• Status: Completed
• Trial end date: 2018-05-09
• Target enrollment: 0
• Participant gender: Male

Summary

An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.

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

Details

• Lead Sponsor: Mereo BioPharma
• Treatments: Acumapimod; Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Healthy male participants.

• Non-smokers (including e-cigarettes).

• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.

• Willing to use highly effective barrier contraception methods.

• Male participants must not donate sperm during the study.

Exclusion Criteria:

• Any participants with pre-existing active skin disease.

• Laboratory values at screening which are deemed to be clinically significant.

• Participants with abnormal liver function tests.

• 12 Lead ECG with QTcF >450 msec.

• Allergy to any of BCT197 excipients.

• Known hypersensitivity or intolerance to itraconazole.

• 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.

• Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.