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NCT02852395
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
Phase 1 trial testing JNJ-48816274 in Healthy in 90 participants. Completed in 2 May 2018.
2 May 2018
Quick facts
| Lead sponsor | Janssen-Cilag International NV |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 13 August 2016 |
| Primary completion | 2 May 2018 |
| Estimated completion | 2 May 2018 |
| Sites | 2 locations across United Kingdom |
Drugs / interventions tested
- JNJ-48816274 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Janssen-Cilag International NV — full company profile →
Who can join
18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential effectiveness for treating insomnia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of the selective orexin-2 receptor antagonist JNJ-48816274 on sleep initiated in the circadian wake maintenance zone: a randomised trial.
Revell VL, Della Monica C, Mendis J, Hassanin H, et al · · 2022 · cited 7× · PMID 34628482 · DOI 10.1038/s41386-021-01175-3
Verify or expand the search:
- PubMed search for NCT02852395
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Janssen-Cilag International NV trials
Trials by the same sponsor.
- NCT04940039 — A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings · Phase 4 · completed
- NCT04338321 — A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selectiv · Phase 3 · completed
- NCT03852160 — A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Stan · Phase 3 · withdrawn
- NCT03947814 — A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment · Phase 1 · terminated
- NCT03816631 — A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02852395 (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 Janssen-Cilag International NV
- Last refreshed: 27 April 2025
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/NCT02852395.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing