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Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers

NCT03775668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-02-26

No results posted yet for this study

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

  • Healthy

Interventions

DRUG

1 µCi of 14C-AAI101 + 500 mg AAI101

Single dose open label

Sponsors & Collaborators

  • Allecra

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2018-12-05
Completion
2019-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03775668 on ClinicalTrials.gov