The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

NCT03498170 | Completed Phase 1 FDA Drug

• 1 other identifier: MBCT103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.

Conditions

Interaction

Keywords

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (2)

• Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.

  Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.

  Pre-dose to Day 15

• Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole.

  Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.

  Pre-dose to Day 15

Secondary Outcomes (1)

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

  Day 1 to Day 21

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 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7

Drug: BCT197; Drug: Itraconazole 200 mg

Interventions

BCT197 DRUG

Single dose of BCT197

Also known as: Acumapimod

Period 1 and Period 2

Itraconazole 200 mg DRUG

Single dose of itraconazole

Also known as: Sporanox

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 participants.
• Non-smokers (including e-cigarettes).
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
• Willing to use highly effective barrier contraception methods.
• Male participants must not donate sperm during the study.

You may not qualify if:

• Any participants with pre-existing active skin disease.
• Laboratory values at screening which are deemed to be clinically significant.
• Participants with abnormal liver function tests.
• Lead ECG with QTcF \>450 msec.
• Allergy to any of BCT197 excipients.
• Known hypersensitivity or intolerance to itraconazole.
• 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.
• Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.

Sponsors & Collaborators

• Mereo BioPharma: lead

Study Sites (1)

inVentiv Health Clinical Research Services LLC

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

acumapimod; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

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: April 6, 2018
• First Posted: April 13, 2018
• Study Start: March 19, 2018
• Primary Completion: May 3, 2018
• Study Completion: May 9, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)