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

August 3, 2016 updated by: Aerpio Therapeutics

An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Drug: AKB-9778 subcutaneous injection

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion Criteria:

BMI 18 - 33 kg/m2

Exclusion Criteria:

Significant cardiovascular, pulmonary, or renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AKB-9778 Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1	Drug: AKB-9778 subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of radioactive dose recovered in urine and feces Time Frame: 7 days	7 days
Concentration of total radioactivity in blood and plasma Time Frame: 7 days	7 days
Cmax of AKB-9778 and any major metabolites identified Time Frame: 7 days	7 days
Tmax of AKB-9778 and any major metabolites identified Time Frame: 7 days	7 days
AUC of AKB-9778 and any major metabolites identified Time Frame: 7 days	7 days
t1/2 of AKB-9778 and any major metabolites identified Time Frame: 7 days	7 days
Elimination rate of AKB-9778 and any major metabolites identified Time Frame: 7 days	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events and change in vital signs and laboratory values Time Frame: 7 days	7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerpio Therapeutics

Investigators

Study Chair: Akshay Buch, PhD, Aerpio Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

AKB-9778-CI-3004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Healthy

Clinical Trials on AKB-9778 subcutaneous injection

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