Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02526888
• Date of registration: 14/08/2015
• Prospective Registration: Yes
• Primary sponsor: Idorsia Pharmaceuticals Ltd.
• Public title: Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects
• Scientific 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
• Date of first enrolment: September 1, 2015
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02526888
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Marie-Laure Boof, PhD
• Affiliation: Actelion

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: ACT-541468

Drug: Diltiazem

Primary Outcome(s)

Time to reach Cmax of ACT-541468 in plasma [Time Frame: 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]

Area under the plasma concentration-time curve (AUC) of ACT-541468 [Time Frame: 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)]

Maximum plasma concentration (Cmax) of ACT-541468 [Time Frame: 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)]

Secondary ID(s)

AC-078-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors