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The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

Sponsor
Mereo BioPharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02926326
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
30
Duration (Days)
16.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-sequence Study to Evaluate the Effect of Azithromycin on BCT197 Exposure in Healthy Male Subjects
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Drug: BCT197
A single dose of BCT197
Other Names:
  • Acumapimod

    • Drug: Azithromycin
    3 daily doses of Azithromycin

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin. [Day 1 to Day 22]

    Other Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BioKinetic Europe Ltd Belfast United Kingdom BT2 7BA

    Sponsors and Collaborators

    • Mereo BioPharma

    Investigators

    • Study Director: Jacqueline Parkin, PhD FRCP, Mereo BioPharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mereo BioPharma
    ClinicalTrials.gov Identifier:
    NCT02926326
    Other Study ID Numbers:
    • MBCT102
    First Posted:
    Oct 6, 2016
    Last Update Posted:
    Oct 24, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mereo BioPharma
    Healthy Male volunteers
    Additional relevant MeSH terms:
    Azithromycin
    Acumapimod

    Study Results

    No Results Posted as of Oct 24, 2016