Mass Balance Study of NV-5138 in Healthy Male Subjects.
NCT05152680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2022-03-15
Summary
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
[14C]-NV-5138
Single dose, given as oral solution, 1600 mg
Sponsors & Collaborators
-
Supernus Pharmaceuticals, Inc.
collaborator INDUSTRY -
Navitor Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-11
- Primary Completion
- 2021-12-09
- Completion
- 2021-12-09
Countries
- United Kingdom
Study Locations
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