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NCT02881294
A Phase I, Single-center, Open-label, Single-dose Study to Evaluate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of Orally Administered SUVN-G3031 in Healthy Subjects
Phase 1 trial testing SUVN-G3031 in Cognitive Disorders in 24 participants. Completed in 1 September 2017.
1 September 2017
Quick facts
| Lead sponsor | Suven Life Sciences Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 August 2016 |
| Primary completion | 1 September 2017 |
| Estimated completion | 1 September 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SUVN-G3031 — full drug profile →
Conditions studied
- Cognitive Disorders — all drugs for Cognitive Disorders →
Sponsor
Suven Life Sciences Limited — full company profile →
Who can join
Adults 18 to 70, any sex, with Cognitive Disorders. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Area under concentration (AUC)
Time frame: 96 hours -
Maximum observed concentration (Cmax)
Time frame: Day 1
Sponsor's own description
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 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:
- PubMed search for NCT02881294
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SUVN-G3031
Trials testing the same drug.
- NCT04072380 — A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataple · Phase 2 · completed
Other recruiting trials for Cognitive Disorders
Currently open trials in the same condition.
- NCT06895109 — Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty · active not recruiting
- NCT06964581 — Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis · NA · recruiting
Other Suven Life Sciences Limited trials
Trials by the same sponsor.
- NCT06836063 — Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients · Phase 2 · completed
- NCT06705088 — Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants · Phase 1 · completed
- NCT06126497 — Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients · Phase 2 · completed
- NCT04072380 — A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataple · Phase 2 · completed
- NCT03551288 — Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects · 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 NCT02881294 (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 Suven Life Sciences Limited
- Last refreshed: 21 September 2017
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/NCT02881294.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing