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A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT03799978
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Study Description
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Brief Summary:
This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: ACT-541468 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Two way crossover
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Open-label, Randomized, Two Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
Actual Study Start Date : March 9, 2019
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : March 18, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A: ACT-541468 50 mg under fasted conditions
Single oral dose administered on Day 1 under fasted conditions.
 Drug: ACT-541468
ACT-541468 50 mg film-coated tablets
Experimental: Treatment B: ACT-541468 50 mg under fed conditions
Single oral dose administered on Day 1 administered after food intake.
 Drug: ACT-541468
ACT-541468 50 mg film-coated tablets


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic endpoint: AUC0-24 [ Time Frame: Multiple timepoints; duration: up to 48 hours in each treatment period ]
    Area under the plasma concentration-time curve (AUC) from time zero to 24 h


Other Outcome Measures:
  1. Pharmacokinetic endpoint: AUC0-inf [ Time Frame: Multiple timepoints; duration: up to 48 hours in each treatment period ]
    AUC from time zero to infinity

  2. Pharmacokinetic endpoint: Cmax [ Time Frame: Multiple timepoints; duration: up to 48 hours in each treatment period ]
    Maximum plasma concentration

  3. Pharmacokinetic endpoint: tmax [ Time Frame: Multiple timepoints; duration: up to 48 hours in each treatment period ]
    Time to reach maximum plasma concentration

  4. Pharmacokinetic endpoint: t½ [ Time Frame: Multiple timepoints; duration: up to 48 hours in each treatment period ]
    Terminal elimination half-life

  5. Treatment-emergent adverse events [ Time Frame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period ]
  6. Serious treatment-emergent adverse events [ Time Frame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure
  • Healthy male subjects aged between 18 and 45 years (inclusive) at Screening
  • Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening
  • No clinically relevant findings on the physical examination at Screening

Exclusion Criteria:

  • History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
  • Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799978


Locations
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Czechia
CEPHA s.r.o.
Pilsen, Czechia, 323 00
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
More Information
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03799978    
Other Study ID Numbers: ID-078-113
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No