The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

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

Detailed Description
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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.

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

Conditions
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Interaction

Intervention / Treatment
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* Drug: BCT197
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Period 1 and Period 2<br>Period 1 - BCT197 14mg on Day 1 Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3 | Drug: BCT197<br>* A single dose of BCT197<br>* Other names: Acumapimod;Drug: Azithromycin<br>* 3 daily doses of Azithromycin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of Azithromycin. | Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72,96, 144, 168 hours post BCT197 dose on Day 1. Period 2: Pre BCT197 dose, 1, 2, 4, 6, 12, 24, 36, 48,72, 96,144, 168 and 336 hours post BCT197 dose on Day 1. | Pre-dose to Day 15 | 
| Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of Azithromycin. | Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72,96, 144, 168 hours post BCT197 dose on Day 1. Period 2: Pre BCT197 dose, 1, 2, 4, 6, 12, 24, 36, 48,72, 96,144, 168 and 336 hours post BCT197 dose on Day 1. | Pre-dose to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin. |  | Day 1 to Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Male volunteers