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Completed

NCT Number: NCT02719197

First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders

The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy male adults

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site

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
  • Healthy on the basis of physical examination, electrocardiogram and laboratory tests.
  • A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake
  • Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1.
  • Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.

Exclusion criteria

  • 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 treatment
  • Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
  • Any cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations
  • 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

AC-083

Drug

Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg

Placebo

Drug

Placebo capsules matching AC-083 capsules

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: From baseline to end of study (EOS) (up to Day 12)

    Treatment-emergent AEs and treatment emergent serious AEs

  2. Changes from baseline in supine blood pressure

    Time frame: From baseline to EOS (up to Day 12)

    Supine blood pressure (mmHg)

  3. Changes from baseline in electrocardiogram (ECG) variables

    Time frame: From baseline to EOS (up to Day 12)

    ECG variables are to be recorded at rest using a standard 12-lead ECG

  4. Changes from baseline in pulse rate

    Time frame: From baseline to EOS (up to Day 12)

    Pulse rate (bpm)

Secondary outcomes

  1. Maximum plasma concentration (Cmax) following single oral ascending doses

    Time frame: From pre-dose on Day 1 to up to Day 12

    Cmax is derived from the observed plasma concentration-time curves

  2. Time to reach Cmax (tmax) following single oral ascending doses

    Time frame: From pre-dose on Day 1 to up to Day 12

    Tmax is derived from the observed plasma concentration-time curves

  3. Terminal half-life [t(1/2)] following single oral ascending doses

    Time frame: From pre-dose on Day 1 to up to Day 12

  4. Area under the plasma concentration-time curve (AUC) following single oral ascending doses

    Time frame: From pre-dose on Day 1 to up to Day 12

    AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification, from zero to infinity and from zero to 24 h after study drug administration

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2016
Registry last updated
Jul 10, 2018

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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