Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841761
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Midalozam Drug: ACT-132577 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects
Study Start Date : July 1, 2016
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A (Midazolam)
Single dose of Midazolam 8 mg on Day 1
Drug: Midalozam
Syrup for oral use

Experimental: Treatment B1 (ACT-132577)
Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5.
Drug: ACT-132577
Capsules for oral use

Experimental: Treatment B2 (Midazolam + ACT-132577)
Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6
Drug: Midalozam
Syrup for oral use

Drug: ACT-132577
Capsules for oral use




Primary Outcome Measures :
  1. Maximum observed plama concentration (Cmax) [ Time Frame: Midazolam PK sampling on Days 1, 2, 6 and 7 ]
    Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577

  2. Area under the plasma concentration-time curve from zero to infinity (AUC0-∞) [ Time Frame: Midazolam PK sampling on Days 1, 2, 6 and 7 ]
    AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577

  3. Time to reach Cmax (tmax) [ Time Frame: Midazolam PK sampling on Days 1, 2, 6 and 7 ]
    Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577

  4. Terminal half-life (t1/2) [ Time Frame: Midazolam PK sampling on Days 1, 2, 6 and 7 ]
    T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577


Secondary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: From Day 1 to Follow-up (for up to 38 days) ]
  2. Number of subjects with serious adverse events [ Time Frame: From Screening to Follow-up (for up to 59 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 in the local language prior to any study-mandated procedure
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
  • Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests

Exclusion Criteria:

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

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): NCT02841761


Locations
Layout table for location information
United States, New Jersey
Investigator Site
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Layout table for additonal information
Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02841761    
Other Study ID Numbers: AC-080-103
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018