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OpenTrials
Completed

NCT Number: NCT02702648

First-in-man Study of Single and Multiple Ascending Doses 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 adults

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Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

All sexes

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.

Key inclusion Criteria:

  • Signed informed consent
  • Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests
  • Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)
  • Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1
  • Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)
  • Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively

Key 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 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-082

Drug

Hard gelatin capsules for oral administration

Placebo

Drug

Matched placebo capsules for oral administration

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to end of study (up to Day 11)

    Treatment-emergent adverse events and treatment-emergent serious adverse events

  2. Changes from baseline in vital signs

    Time frame: Up to end of study (up to Day 11)

    Vital signs include diastolic and systolic blood pressure and pulse rate

  3. Changes from baseline in ECG variables

    Time frame: Up to end of study (up to day 11)

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

Secondary outcomes

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

    Time frame: From pre-dose on Day 1 to 96 hours post dose

    Cmax is derived from the observed plasma concentration-time curves

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

    Time frame: From pre-dose on Day 1 to 96 hours post dose

    tmax is derived from the observed plasma concentration-time curves

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

    Time frame: From pre-dose on Day 1 to 96 hours post dose

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

    Time frame: From pre-dose on Day 1 to 96 hours post dose

    AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification [AUC(0-t)] and from zero to infinity [AUC(0-inf)]

  5. Maximum plasma concentration (Cmax) following multiple ascending doses

    Time frame: Up to 96 hours following the last dose administration on Day 4

  6. Time to reach Cmax (tmax) following multiple ascending doses

    Time frame: Up to 96 hours following the last dose administration on Day 4

  7. Terminal half-life [t(1/2)] following multiple ascending doses

    Time frame: Up to 96 hours following the last dose administration on Day 4

    t(1/2) on the last day of dosing

  8. Area under the plasma concentration-time curve during a dosing interval (AUCtau)

    Time frame: Day 1 and Day 4

    AUCtau is the area under the plasma concentration-time curve during a dosing interval

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 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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