The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2018-05-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Interaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

BCT197

Intervention Type DRUG

Single dose of BCT197

Itraconazole 200 mg

Intervention Type DRUG

Single dose of itraconazole

Interventions

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BCT197

Single dose of BCT197

Intervention Type DRUG

Itraconazole 200 mg

Single dose of itraconazole

Intervention Type DRUG

Other Intervention Names

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Acumapimod Sporanox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes