The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants
- Registration Number
- NCT03498170
- Lead Sponsor
- Mereo BioPharma
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Period 1 and Period 2 Itraconazole 200 mg Period 1 - BCT197 14mg on Day 1 Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7 Period 1 and Period 2 BCT197 Period 1 - BCT197 14mg on Day 1 Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7
- Primary Outcome Measures
Name Time Method Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole. Pre-dose to Day 15 Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1.
Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole. Pre-dose to Day 15 Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1.
Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
- Secondary Outcome Measures
Name Time Method The number of adverse events during administration of BCT197 alone and in the presence of itraconazole. Day 1 to Day 21
Trial Locations
- Locations (1)
inVentiv Health Clinical Research Services LLC
🇺🇸Miami, Florida, United States