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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. Identifier: NCT03165097
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : January 3, 2019
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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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 24, 2017
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : November 15, 2018

Arm Intervention/treatment
Experimental: ACT-709478

Up to 30 healthy male and female subjects (40 subjects if the optional fourth dose level is conducted) will receive multiple doses of ACT-709478 at the planned dose levels of 30, 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

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

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

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 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 identifier (NCT number): NCT03165097

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Berlin, Germany, 14050
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
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Study Director: Margaux Boehler, PharmD Actelion

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Responsible Party: Idorsia Pharmaceuticals Ltd. Identifier: NCT03165097     History of Changes
Other Study ID Numbers: AC-083-102
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: July 2018
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.: