The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

NCT02926326 | Completed Phase 1

• 1 other identifier: MBCT102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Interaction

Keywords

Healthy Male volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin.

  Day 1 to Day 22

Other Outcomes (1)

• Corrected QT interval of the electrocardiogram (QTc).

  Pre-dose to Day 15

Study Arms (1)

Period 1 and Period 2

OTHER

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; Drug: Azithromycin

Interventions

BCT197 DRUG

A single dose of BCT197

Also known as: Acumapimod

Period 1 and Period 2

Azithromycin DRUG

3 daily doses of Azithromycin

Period 1 and Period 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mereo BioPharma: lead

Study Sites (1)

BioKinetic Europe Ltd

Belfast, BT2 7BA, United Kingdom

Location

MeSH Terms

Interventions

acumapimod; Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jacqueline Parkin, PhD FRCP

  Mereo BioPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 24, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)