First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders

NCT02702648 | Completed Phase 1

• 1 other identifier: AC-082-101
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

healthy subjects; first-in-man; safety

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AEs)

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

  Up to end of study (up to Day 11)

• Changes from baseline in vital signs

  Vital signs include diastolic and systolic blood pressure and pulse rate

  Up to end of study (up to Day 11)

• Changes from baseline in ECG variables

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

  Up to end of study (up to day 11)

Secondary Outcomes (8)

• Maximum plasma concentration (Cmax) following single ascending doses

  From pre-dose on Day 1 to 96 hours post dose

• Time to reach Cmax (tmax) following single ascending doses

  From pre-dose on Day 1 to 96 hours post dose

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

  From pre-dose on Day 1 to 96 hours post dose

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

  From pre-dose on Day 1 to 96 hours post dose

• Maximum plasma concentration (Cmax) following multiple ascending doses

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

Study Arms (4)

AC-082, Single Ascending Dose

EXPERIMENTAL

Subjects receive AC-082 at different single dose levels in a sequential manner, starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each subject can participate in only one dose level

Drug: AC-082

Placebo, Single Ascending Dose

PLACEBO COMPARATOR

Subjects receive a single dose of the matched placebo

Drug: Placebo

AC-082, Multiple Ascending Dose

EXPERIMENTAL

Subjects receive AC-082 at different dose levels for 4 consecutive days in a sequential manner (dose levels and duration to be adapted according to the results of the single ascending dose cohorts). Each subject can participate in only one dose level

Drug: AC-082

Placebo, Multiple Ascending Dose

PLACEBO COMPARATOR

Subjects receive the matched placebo for 4 days

Drug: Placebo

Interventions

AC-082 DRUG

Hard gelatin capsules for oral administration

AC-082, Multiple Ascending Dose; AC-082, Single Ascending Dose

Placebo DRUG

Matched placebo capsules for oral administration

Placebo, Multiple Ascending Dose; Placebo, Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Investigator Site

Berlin, 14050, Germany

Location

Study Officials

• Karine Litherland, PhD

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

DE (1)