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Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778

NCT ID: NCT02858271

Last Updated: 2016-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-07-31

Brief Summary

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Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of \[14C\]-AKB-9778 in healthy male volunteers

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AKB-9778

Single dose of \[14C\]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1

Group Type EXPERIMENTAL

AKB-9778 subcutaneous injection

Intervention Type DRUG

Interventions

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AKB-9778 subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 18 - 33 kg/m2

Exclusion Criteria

* Significant cardiovascular, pulmonary, or renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aerpio Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akshay Buch, PhD

Role: STUDY_CHAIR

Aerpio Therapeutics

Other Identifiers

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AKB-9778-CI-3004

Identifier Type: -

Identifier Source: org_study_id

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