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

NCT02719197 | Completed Phase 1

• 2 other identifiers: AC-083-1012015-005012-15
• Study Type: interventional
• Target: 72
• 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 male adults

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs)

  Treatment-emergent AEs and treatment emergent serious AEs

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

• Changes from baseline in supine blood pressure

  Supine blood pressure (mmHg)

  From baseline to EOS (up to Day 12)

• Changes from baseline in electrocardiogram (ECG) variables

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

  From baseline to EOS (up to Day 12)

• Changes from baseline in pulse rate

  Pulse rate (bpm)

  From baseline to EOS (up to Day 12)

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax) following single oral ascending doses

  From pre-dose on Day 1 to up to Day 12

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

  From pre-dose on Day 1 to up to Day 12

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

  From pre-dose on Day 1 to up to Day 12

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

  From pre-dose on Day 1 to up to Day 12

Study Arms (2)

AC-083, Single Ascending Dose

EXPERIMENTAL

AC-083 administered at different single dose levels in a sequential manner, and in a maximum of 9 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo)

Drug: AC-083

Placebo, Single Ascending Dose

PLACEBO COMPARATOR

Matched placebo administered as single ascending doses in parallel to AC-083

Drug: Placebo

Interventions

AC-083 DRUG

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

AC-083, Single Ascending Dose

Placebo DRUG

Placebo capsules matching AC-083 capsules

Placebo, Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Investigator Site

Berlin, 14050, Germany

Location

Study Design

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

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 25, 2016
• Study Start: February 19, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)