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

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

Study Overview

• Status: Completed
• Conditions: Interaction
• Intervention / Treatment: Drug: BCT197; Drug: Azithromycin

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT2 7BA
    • BioKinetic Europe Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mereo BioPharma

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 28, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Healthy Male volunteers
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Kinase Inhibitors; Azithromycin; Acumapimod
• Other Study ID Numbers: MBCT102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No