The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

Study Overview
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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.

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.

Official Title
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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

Conditions
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Interaction

Intervention / Treatment
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* Drug: BCT197
* Drug: Itraconazole 200 mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Period 1 and Period 2<br>Period 1 - BCT197 14mg on Day 1 Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7 | Drug: BCT197<br>* Single dose of BCT197<br>* Other names: Acumapimod;Drug: Itraconazole 200 mg<br>* Single dose of itraconazole<br>* Other names: Sporanox;|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events during administration of BCT197 alone and in the presence of itraconazole. |  | Day 1 to Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Male Volunteers