The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498170
• Other study ID #: MBCT103
• Status: Completed
• Phase: Phase 1
• Start date: March 19, 2018
• Est. completion date: May 9, 2018

Study information

• Verified date: April 2018
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 9, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Interaction

Intervention

Drug:
• BCT197
Single dose of BCT197
• Itraconazole 200 mg
Single dose of itraconazole

Locations

Country	Name	City	State
United States	inVentiv Health Clinical Research Services LLC	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mereo BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	The number of adverse events during administration of BCT197 alone and in the presence of itraconazole.		Day 1 to Day 21