The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-10-31

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.

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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.

Conditions

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Interaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1 and Period 2

Period 1 - BCT197 14mg on Day 1

Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3

Group Type OTHER

BCT197

Intervention Type DRUG

A single dose of BCT197

Azithromycin

Intervention Type DRUG

3 daily doses of Azithromycin

Interventions

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BCT197

A single dose of BCT197

Intervention Type DRUG

Azithromycin

3 daily doses of Azithromycin

Intervention Type DRUG

Other Intervention Names

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Acumapimod

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes