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

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): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• BMI 18 - 33 kg/m2

Exclusion Criteria:

• Significant cardiovascular, pulmonary, or renal disease

Study Plan

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

1

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	7 days
Concentration of total radioactivity in blood and plasma	7 days
Cmax of AKB-9778 and any major metabolites identified	7 days
Tmax of AKB-9778 and any major metabolites identified	7 days
AUC of AKB-9778 and any major metabolites identified	7 days
t1/2 of AKB-9778 and any major metabolites identified	7 days
Elimination rate of AKB-9778 and any major metabolites identified	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aerpio Therapeutics
• Investigators: Study Chair: Akshay Buch, PhD, Aerpio Therapeutics

Study record dates

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No