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Completed

NCT Number: NCT03165097

Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT-709478

Drug

Hard gelatine capsules for oral administration

Placebo

Drug

Placebo capsules matching ACT-709478 capsules

midazolam

Drug

Midazolam oral solution (2 mg/mL) applied with a syringe

ACT-709478 combined with midazolam

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2017
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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