The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

Mereo BioPharma

Status and phase

Completed

Phase 1

Conditions

Interaction

Treatments

Drug: Itraconazole 200 mg

Drug: BCT197

Study type

Interventional

Funder types

Industry

Identifiers

NCT03498170

MBCT103

Details and patient eligibility

About

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.

Full description

This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.

Enrollment

16 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.