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NCT05384977
Mass Balance Study of NV-5138 in Healthy Male Subjects
Phase 1 trial testing [14C]-NV-5138 in Healthy Volunteers in 6 participants. Completed in 9 December 2021.
9 December 2021
Quick facts
| Lead sponsor | Supernus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 11 November 2021 |
| Primary completion | 9 December 2021 |
| Estimated completion | 9 December 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- [14C]-NV-5138 — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Supernus Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 40 to 65, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to assess the mass balance and routes of excretion of total radioactivity after a single oral dose of 1600 mg \[14C\]-NV-5138.
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 NCT05384977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of [14C]-NV-5138
Trials testing the same drug.
- NCT05152680 — Mass Balance Study of NV-5138 in Healthy Male Subjects. · Phase 1 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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Other Supernus Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07226661 — Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder · Phase 2 · recruiting
- NCT07141329 — SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07219927 — Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: · recruiting
- NCT06185985 — Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms · Phase 4 · completed
- NCT06259331 — Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women · Phase 4 · 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 NCT05384977 (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 Supernus Pharmaceuticals, Inc.
- Last refreshed: 23 May 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/NCT05384977.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing