The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02926326

Enrollment

Registered

2016-10-06

Start date

2016-09-30

Completion date

2016-10-31

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interaction

Keywords

Healthy Male volunteers

Brief summary

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

Detailed description

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.

Interventions

DRUGBCT197

A single dose of BCT197

DRUGAzithromycin

3 daily doses of Azithromycin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of Azithromycin.	Pre-dose to Day 15	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.
Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of Azithromycin.	Pre-dose to Day 15	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.

Secondary

Measure	Time frame
The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin.	Day 1 to Day 22

Other

Measure	Time frame	Description
Corrected QT interval of the electrocardiogram (QTc).	Pre-dose to Day 15	Period 1: Pre-dose, 1, 2, 4, 6, 8, 24 and 168 hours post BCT197 dose on Day 1. Period 2: -22 hours, -16 hours, pre-dose azithromycin, 2, 4, 6, 8, 24, 168 and 336 hours post-dose (BCT197 on Day 1).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026