Study to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects Suffering From Difficulties to Sleep

• Status: Completed
• Trial end date: 2021-02-22
• Target enrollment: 0
• Participant gender: All

Summary

Study to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Criteria

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure (Visit 1).

• Having completed the DB study treatment and the run-out period of ID-078A301 or ID-078A302 (Visit 1).

• For woman of childbearing potential, the following is required:

• Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)

• Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

• Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).

• For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).

• Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).