NCT03869320 is a Phase 1 clinical trial of ACT-1004-1239 in Healthy, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT03869320?

NCT03869320 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT03869320?

Interventions in NCT03869320: ACT-1004-1239, Placebo, ACT-1004-1239 (Food-effect subpart), Placebo (Food-effect subpart).

Is NCT03869320 still recruiting?

NCT03869320 is currently completed. Last updated 10 January 2020.

Last reviewed 2020-01-10 · How we verify

NCT03869320

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

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects

Completed Phase 1 Last updated 10 January 2020

What this trial tests

Phase 1 trial testing ACT-1004-1239 in Healthy in 64 participants. Completed in 11 July 2019.

Timeline

25 March 2019

Primary endpoint
11 July 2019

11 July 2019

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	64
Start date	25 March 2019
Primary completion	11 July 2019
Estimated completion	11 July 2019
Sites	1 location across United States

Drugs / interventions tested

ACT-1004-1239 — full drug profile →
Placebo
ACT-1004-1239 (Food-effect subpart) — full drug profile →
Placebo (Food-effect subpart)

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

This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
ACT-1004-1239, a first-in-class CXCR7 antagonist with both immunomodulatory and promyelinating effects for the treatment of inflammatory demyelinating diseases.
Pouzol L, Baumlin N, Sassi A, Tunis M, et al · · 2021 · cited 28× · PMID 33595155 · DOI 10.1096/fj.202002465r
CXC Chemokines in the Pathogenesis of Pulmonary Disease and Pharmacological Relevance.
Komolafe K, Pacurari M. · · 2022 · cited 21× · PMID 36164329 · DOI 10.1155/2022/4558159
Absorption, Metabolism, and Excretion of ACT-1004-1239, a First-In-Class CXCR7 Antagonist: <i>In Vitro</i>, Preclinical, and Clinical Data.
Huynh C, Seeland S, Segrestaa J, Gnerre C, et al · · 2022 · cited 5× · PMID 35431953 · DOI 10.3389/fphar.2022.812065
Pharmacological modulation of CXCL12/CXCR4/ACKR3 for brain disorders - an overview.
Kuppens A, Rogister B, Neirinckx V. · · 2026 · PMID 42026661 · DOI 10.1186/s12964-026-02877-1

Verify or expand the search:

Other trials of ACT-1004-1239

Trials testing the same drug.

NCT04286750 — Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasin · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

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 NCT03869320 (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: 10 January 2020

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/NCT03869320.

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