Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Effect of Multiple-dose Diltiazem on the Pharmacokinetics of a Single Dose of 25 mg ACT-541468 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526888
• Other study ID #: AC-078-103
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2015
• Est. completion date: November 1, 2015

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468

Description:

Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468.

Safety of the concomitant administration of the two drugs will also be assessed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 1, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening

• Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests

Exclusion Criteria:

• Any contraindication to the study drugs

• History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs

• History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0

• Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ACT-541468
Oral capsule (25 mg) as single dose
• Diltiazem
Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of safety events of interest	Events of interest are any abnormalities in ECG, vital signs or laboratory test results	From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)
Other	Incidence of adverse events	Number of participants with any adverse events, including laboratory abnormalities	From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)
Primary	Maximum plasma concentration (Cmax) of ACT-541468	Cmax will be directly derived from the plasma concentration time curves of ACT-541468	From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)
Primary	Time to reach Cmax of ACT-541468 in plasma	tmax will be directly derived from the plasma concentration time curves of ACT-541468	From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA
Primary	Area under the plasma concentration-time curve (AUC) of ACT-541468	AUC will be calculated for the following time frame: from time zero to the last measured concentration above the limit of quantification and from time zero to infinitiy	From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)