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NCT02342041
A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-G3031 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
Phase 1 trial testing SUVN-G3031 in Cognitive Disorders in 64 participants. Completed in 1 August 2015.
1 June 2015
Quick facts
| Lead sponsor | Suven Life Sciences Limited |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 1 September 2014 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 August 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SUVN-G3031 — full drug profile →
- Placebo
Conditions studied
- Cognitive Disorders — all drugs for Cognitive Disorders →
Sponsor
Suven Life Sciences Limited — full company profile →
Who can join
Adults 18 to 45, male only, 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.
-
Safety and tolerability of single or multiple doses of SUVN-G3031 in healthy male subjects
Time frame: Range of Day 1-19
Safety variables - Adverse events, vital signs, electrocardiograms, telemetry, physical examination, and clinical laboratory assessments.
Sponsor's own description
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drug candidates in clinical trials for Alzheimer's disease.
Hung SY, Fu WM. · · 2017 · cited 281× · PMID 28720101 · DOI 10.1186/s12929-017-0355-7 -
Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses.
Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, et al · · 2020 · cited 8× · PMID 32399853 · DOI 10.1007/s40261-020-00920-8
Verify or expand the search:
- PubMed search for NCT02342041
- 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 NCT02342041 (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 Suven Life Sciences Limited
- Last refreshed: 13 October 2016
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/NCT02342041.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing