NCT02526888

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

August 14, 2015

Last Update Submit

July 6, 2018

Conditions

Healthy Subjects

Keywords

pharmacokineticinteraction

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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

  • 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)

Other Outcomes (2)

  • Incidence of safety events of interest

    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)

  • Incidence of adverse events

    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)

Study Arms (2)

Sequence AB

EXPERIMENTAL

During Period 1, subjects receive a single dose of ACT-541468 on Day 1. During Period 2, they receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4

Drug: ACT-541468Drug: Diltiazem

Sequence BA

EXPERIMENTAL

During Period 1, subjects receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4. During Period 2, they receive a single dose of ACT-541468 on Day 1

Drug: ACT-541468Drug: Diltiazem

Interventions

ACT-541468DRUG

Oral capsule (25 mg) as single dose

Sequence ABSequence BA
DiltiazemDRUG

Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7

Sequence ABSequence BA

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

MeSH Terms

Interventions

daridorexantDiltiazem

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Marie-Laure Boof, PhD

    Actelion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

DE(1)