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Trial record 75 of 87731 for:    subjects

Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy 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: NCT03165097
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ACT-709478 Drug: Placebo Drug: Midazolam Drug: ACT-709478 combined with midazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Single-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Multiple-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-709478 in Healthy Subjects
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Midazolam

Arm Intervention/treatment
Experimental: ACT-709478

40 subjects will receive multiple doses of ACT-709478 at the planned dose levels of 30, 60, 100, and 200 mg.

Each dose level will be investigated in a new cohort of 10 healthy male and female subjects (4 male subjects on active drug and 1 on placebo, 4 female subjects on active drug and 1 on placebo) undergoing one treatment period with a once daily dosing scheme.

Drug: ACT-709478
Hard gelatine capsules for oral administration

Placebo Comparator: Placebo
Matched placebo administered accordingly
Drug: Placebo
Placebo capsules matching ACT-709478 capsules

Midazolam
4 mg taken by mouth on Day 1 of the corresponding cohort
Drug: Midazolam
Midazolam oral solution (2 mg/mL) applied with a syringe

Experimental: ACT-709478 combined with Midazolam
On Day 22 and Day 30, midazolam (4 mg) and ACT-709478 (60 mg or 100 mg) to be co-administered.
Drug: ACT-709478 combined with midazolam
Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: up to Day 23 ]
    The percentage of subjects with treatment-emergent adverse events will be reported

  2. Changes from baseline in vital signs [ Time Frame: up to Day 23 ]
    Vital signs include diastolic and systolic blood pressure and pulse rate

  3. Incidence of any clinical relevant findings in ECG variables [ Time Frame: up to Day 23 ]
    The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of ACT-709478 [ Time Frame: up to Day 23 ]
    Cmax is derived from the observed plasma concentration-time curves

  2. Time to reach Cmax (tmax) of ACT-709478 [ Time Frame: up to Day 23 ]
    tmax is directly derived from the observed plasma concentrations

  3. Terminal half-life (t1/2) of ACT-709478 [ Time Frame: up to Day 23 ]
    t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves

  4. Area under the plasma concentration-time curve AUC(tau) of ACT-709478 [ Time Frame: up to Day 23 ]
    AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval

  5. Area under the plasma concentration-time curve AUC(tau) of midazolam [ Time Frame: 24 hours after dosing on Day 1, Day 22 and Day 30 ]
    AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval

  6. Time to reach Cmax (tmax) [ Time Frame: 24 hours after dosing on Day 1, Day 22 and Day 30 ]
    tmax is directly derived from the observed plasma concentrations

  7. Maximum plasma concentration (Cmax) of ACT-709478 [ Time Frame: 24 hours after dosing on Day 1, Day 22 and Day 30 ]
    Cmax is derived from the observed plasma concentration-time curves



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent form
  • Healthy male and female subjects aged between 18 and 55 years (inclusive) at screening
  • Negative serum pregnancy tests at screening and negative urine pregnancy test at Day -1 for women and agreement to use 2 reliable methods of contraception for at least 3 months after last study drug administration
  • Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening
  • Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 minutes in the supine position at screening and on Day -1
  • Healthy on the basis of physical examination, cardiovascular, ophthalmological, neurological assessments and laboratory tests

Exclusion Criteria:

  • Known hypersensitivity to ACT-709478 or drugs of the same class, or any of their excipients
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments
  • QT interval corrected with Fridericia's formula (QTcF) > 450 ms (using the ECG machine HR correction method) at screening and on Day -1
  • Treatment with another investigational treatment within 2 months or 5 t1/2 (whichever is the longest) prior to screening or participation in more than four investigational treatment studies within 1 year prior to screening
  • 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): NCT03165097


Locations
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Germany
Parexel
Berlin, Germany, 14050
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Study Director Idorsia Pharmaceuticals Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03165097    
Other Study ID Numbers: AC-083-102
2017-000336-34 ( EudraCT Number )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Idorsia Pharmaceuticals Ltd.:
tolerability
safety
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action