The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Interaction
• Interventions: Drug: BCT197; Drug: Azithromycin

• Registration Number: NCT02926326
• Lead Sponsor: Mereo BioPharma

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-28
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Period 1 and Period 2	BCT197	Period 1 - BCT197 14mg on Day 1 Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3
Period 1 and Period 2	Azithromycin	Period 1 - BCT197 14mg on Day 1 Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BioKinetic Europe Ltd; 🇬🇧 Belfast, United Kingdom