NCT05549531 is a Phase 1 clinical trial of ACT-1004-1239 (10 mg) in Healthy, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT05549531?

NCT05549531 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT05549531?

Interventions in NCT05549531: ACT-1004-1239 (10 mg), Itraconazole (200 mg, o.d.).

Is NCT05549531 still recruiting?

NCT05549531 is currently completed. Last updated 8 November 2022.

Last reviewed 2022-11-08 · How we verify

NCT05549531

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

A Study to Investigate the Effect of Itraconazole on the Way the Body Absorbs, Distributes, and Gets Rid of ACT-1004-1239 Given as a Single Dose of 10 mg to Healthy Male Subjects

Completed Phase 1 Last updated 8 November 2022

What this trial tests

Phase 1 trial testing ACT-1004-1239 (10 mg) in Healthy in 16 participants. Completed in 20 October 2022.

Timeline

1 October 2022

Primary endpoint
20 October 2022

20 October 2022

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	16
Start date	1 October 2022
Primary completion	20 October 2022
Estimated completion	20 October 2022
Sites	1 location across Portugal

Drugs / interventions tested

ACT-1004-1239 (10 mg) — full drug profile →
Itraconazole (200 mg, o.d.) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

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

Sponsor's own description

A study to investigate the effect of itraconazole on the way the body absorbs, distributes, and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of the first-in-class ACKR3/CXCR7 antagonist, ACT-1004-1239.
Huynh C, Dingemanse J, Meyer Zu Schwabedissen HE, Fonseca M, et al · · 2024 · cited 3× · PMID 39010703 · DOI 10.1111/cts.13883

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 NCT05549531 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 8 November 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/NCT05549531.

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