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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: AC-083

Study type: Interventional

Funder types: Industry

Identifiers

NCT02719197

2015-005012-15 (EudraCT Number)

AC-083-101

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

72 participants in 2 patient groups, including a placebo group

AC-083, Single Ascending Dose

Experimental group

Description:

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)

Treatment:

Drug: AC-083

Placebo, Single Ascending Dose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo