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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03498170

Enrollment

Registered

2018-04-13

Start date

2018-03-19

Completion date

2018-05-09

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interaction

Keywords

Healthy Male Volunteers

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.

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.

Interventions

DRUGBCT197

Single dose of BCT197

DRUGItraconazole 200 mg

Single dose of itraconazole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.	Pre-dose to Day 15	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.
Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole.	Pre-dose to Day 15	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.

Secondary

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

Measure	Time frame	Description
Corrected QT interval of the electrocardiogram (QTc).	Pre-dose to Day 15	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026