The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

Completed · Phase 1

Conditions studied: Interaction

In brief

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.

Key facts

Study ID

NCT03498170

Run by

Mereo BioPharma

People needed

16

Starts

2018-03-19

Expected to finish

2018-05-09

Last updated by the study team

2018-05-18

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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