NCT04798209 is a Phase 1 clinical trial of ACT-777991 (SAD) in Healthy, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT04798209?

NCT04798209 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT04798209?

Interventions in NCT04798209: ACT-777991 (SAD), ACT-777991 (MAD), Placebo (SAD), Placebo (MAD), 14C-ACT-777991 microtracer (SAD - Absolute Bioavailability), Microtracer matching placebo (SAD - Absolute Bioavailability), 14C-ACT-777991 microtracer (MAD - ADME), Microtracer matching placebo (MAD - ADME).

Is NCT04798209 still recruiting?

NCT04798209 is currently completed. Last updated 21 June 2022.

Last reviewed 2022-06-21 · How we verify

NCT04798209

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects

Completed Phase 1 Last updated 21 June 2022

What this trial tests

Phase 1 trial testing ACT-777991 (SAD) in Healthy in 70 participants. Completed in 21 May 2022.

Timeline

29 January 2021

Primary endpoint
26 January 2022

21 May 2022

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	other
Enrollment	70
Start date	29 January 2021
Primary completion	26 January 2022
Estimated completion	21 May 2022
Sites	1 location across Netherlands

Drugs / interventions tested

ACT-777991 (SAD)
ACT-777991 (MAD)
Placebo (SAD) — full drug profile →
Placebo (MAD)
14C-ACT-777991 microtracer (SAD - Absolute Bioavailability) — full drug profile →
Microtracer matching placebo (SAD - Absolute Bioavailability) — full drug profile →
14C-ACT-777991 microtracer (MAD - ADME) — full drug profile →
Microtracer matching placebo (MAD - ADME) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-777991 in healthy subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Idorsia Pharmaceuticals Ltd. trials

Trials by the same sponsor.

NCT06799884 — A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormo · Phase 1 · completed
NCT05877222 — A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in · Phase 1 · completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia · Phase 4 · completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women · Phase 1 · completed
NCT05702177 — A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04798209 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Idorsia Pharmaceuticals Ltd.
Last refreshed: 21 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04798209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing