Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects

Idorsia Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Midazolam

Drug: ACT-709478 combined with midazolam

Drug: ACT-709478

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03165097

2017-000336-34 (EudraCT Number)

AC-083-102

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects

Enrollment

46 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed informed consent form
Healthy male and female subjects aged between 18 and 55 years (inclusive) at screening
Negative serum pregnancy tests at screening and negative urine pregnancy test at Day -1 for women and agreement to use 2 reliable methods of contraception for at least 3 months after last study drug administration
Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening
Systolic blood pressure 100-140 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 minutes in the supine position at screening and on Day -1
Healthy on the basis of physical examination, cardiovascular, ophthalmological, neurological assessments and laboratory tests

Exclusion criteria

Known hypersensitivity to ACT-709478 or drugs of the same class, or any of their excipients
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 treatments
QT interval corrected with Fridericia's formula (QTcF) > 450 ms (using the ECG machine HR correction method) at screening and on Day -1
Treatment with another investigational treatment within 2 months or 5 t1/2 (whichever is the longest) prior to screening or participation in more than four investigational treatment studies within 1 year prior to screening
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

Quadruple Blind

46 participants in 4 patient groups, including a placebo group

ACT-709478

Experimental group

Description:

40 subjects will receive multiple doses of ACT-709478 at the planned dose levels of 30, 60, 100, and 200 mg. Each dose level will be investigated in a new cohort of 10 healthy male and female subjects (4 male subjects on active drug and 1 on placebo, 4 female subjects on active drug and 1 on placebo) undergoing one treatment period with a once daily dosing scheme.

Treatment:

Drug: ACT-709478

Placebo

Placebo Comparator group

Description:

Matched placebo administered accordingly

Treatment:

Drug: Placebo

Midazolam

Other group

Description:

4 mg taken by mouth on Day 1 of the corresponding cohort