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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03498170
Other study ID # MBCT103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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