The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Interaction
• Intervention / Treatment: Drug: BCT197; Drug: Itraconazole 200 mg

Detailed Description

This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.

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

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • inVentiv Health Clinical Research Services LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 12 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.

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 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7	Drug: BCT197; Single dose of BCT197; Other Names: Acumapimod; Drug: Itraconazole 200 mg; Single dose of itraconazole; Other Names: Sporanox

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 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 Outcome Measures

Outcome Measure	Time Frame
The number of adverse events during administration of BCT197 alone and in the presence of itraconazole.	Day 1 to Day 21

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected QT interval of the electrocardiogram (QTc).	Period 1: Pre-dose, 2, 4, 6, 8, 24 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose, 2, 4, 6, 8, 24, 168 and 192 hours post BCT197 dose on Day 7.	Pre-dose to Day 15

Collaborators and Investigators

• Sponsor: Mereo BioPharma

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): May 9, 2018

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Male Volunteers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Protein Kinase Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; Acumapimod
• Other Study ID Numbers: MBCT103

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No