Trials / Completed
CompletedNCT03775668
Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers
A Phase 1, Open-Label, Single-Dose Study to Assess the Mass Balance, Pharmacokinetics and Metabolism of Intravenously Administered 14C-AAI101 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Allecra · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in the United States (USA). This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered 14C-AAI101.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 1 µCi of 14C-AAI101 + 500 mg AAI101 | Single dose open label |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2018-12-05
- Completion
- 2019-01-31
- First posted
- 2018-12-14
- Last updated
- 2019-02-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03775668. Inclusion in this directory is not an endorsement.