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

Aerpio Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AKB-9778 subcutaneous injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02858271

AKB-9778-CI-3004

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 18 - 33 kg/m2

Exclusion criteria

• Significant cardiovascular, pulmonary, or renal disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

AKB-9778

Experimental group

Description:

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

Treatment:

Drug: AKB-9778 subcutaneous injection