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

Aerpio Therapeutics6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AKB-9778 subcutaneous injectionDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 18 - 33 kg/m2 Exclusion Criteria: * Significant cardiovascular, pulmonary, or renal disease

Outcomes

Primary Outcomes

Percent of radioactive dose recovered in urine and feces

Time frame: 7 days

Concentration of total radioactivity in blood and plasma

Time frame: 7 days

Cmax of AKB-9778 and any major metabolites identified

Time frame: 7 days

Tmax of AKB-9778 and any major metabolites identified

Time frame: 7 days

AUC of AKB-9778 and any major metabolites identified

Time frame: 7 days

t1/2 of AKB-9778 and any major metabolites identified

Time frame: 7 days

Elimination rate of AKB-9778 and any major metabolites identified

Time frame: 7 days

Secondary Outcomes

Incidence of adverse events and change in vital signs and laboratory values

Time frame: 7 days

Data from ClinicalTrials.gov

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