The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926326
• Other study ID #: MBCT102
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2016
• Last updated: October 21, 2016
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Northern Ireland: Ethics Committees
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interaction

Intervention

Drug:
• BCT197
A single dose of BCT197
• Azithromycin
3 daily doses of Azithromycin

Locations

Country	Name	City	State
United Kingdom	BioKinetic Europe Ltd	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Mereo BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corrected QT interval of the electrocardiogram (QTc).	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).	Pre-dose to Day 15	No
Primary	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	No
Primary	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	No
Secondary	The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin.		Day 1 to Day 22	Yes