A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03017495
• Date of registration: 10/01/2017
• Prospective Registration: No
• Primary sponsor: Idorsia Pharmaceuticals Ltd.
• Public title: A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
• Scientific title: A Single-center, Open-label Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 and the Effect of Single- and Multiple-dose ACT-541468 on the Pharmacokinetics of Midazolam and Its Metabolite 1-Hydroxymidazolam in Healthy Male Subjects
• Date of first enrolment: January 1, 2017
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03017495
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group 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 form

- Male subjects aged from 18 to 45 years (inclusive) at screening

- Body mass index (BMI) from 18.0 to 30.0 kg/m2 (inclusive) at screening

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

Exclusion Criteria:

- Any contraindication to the study treatments

- History or clinical evidence of any disease or medical / surgical 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
treatments

- 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: Midazolam

Primary Outcome(s)

Area under the plasma concentration-time curve [AUC(0-24)] of midazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Maximum plasma concentration (Cmax) of 1-hydroxymidazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Terminal half-life (t1/2) of 1-hydroxymidazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Time to reach Cmax (tmax) of 1-hydroxymidazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Time to reach Cmax (tmax) of ACT-541468 [Time Frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only]

Terminal half-life (t1/2) of ACT-541468 [Time Frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only]

Maximum plasma concentration (Cmax) of midazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Area under the plasma concentration-time curve [AUC(0-24)] of ACT-541468 [Time Frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only]

Maximum plasma concentration (Cmax) of ACT-541468 [Time Frame: PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only]

Terminal half-life (t1/2) of midazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Time to reach Cmax (tmax) of midazolam [Time Frame: PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose]

Secondary Outcome(s)

Time to reach Cmax (tmax) of ACT-541468 metabolites [Time Frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose]

Area under the plasma concentration-time curve [AUC(0-24)] of ACT-541468 metabolites [Time Frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose]

Terminal half-life (t1/2) of ACT-541468 metabolites [Time Frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose]

Maximum plasma concentration (Cmax) of ACT-541468 metabolites [Time Frame: PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose]

Number of subjects with treatment-emergent adverse events and serious adverse events [Time Frame: From baseline to end-of-study, i.e.,maximum 5 days after Day 8]

Secondary ID(s)

2016-003490-18

AC-078-104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors