CompletedNCT02858271Updated Aug 8, 2016

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

A Phase 1 interventional study of AKB-9778 subcutaneous injection in Healthy, sponsored by Aerpio Therapeutics. Completed. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-08.

Sponsored by Aerpio Therapeutics · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 6
Allocation: Not applicable
Ages: 18 Years to 60 Years
Sex: Male

Study summary

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

Conditions studied

Healthy

In context

Lead sponsor

Aerpio Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

BMI 18 - 33 kg/m2

Exclusion criteria

Exclusion Criteria:

Significant cardiovascular, pulmonary, or renal disease

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 6 participants (actual)

Study arms

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

Interventions

DrugAKB-9778 subcutaneous injection

What researchers measure

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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02858271
Lead sponsor: Aerpio Therapeutics
Responsible party: Sponsor
First posted: Aug 8, 2016
Start date: Jul 2016
Primary completion: Jul 2016
Completion: Jul 2016
Last update: Aug 8, 2016

Study contacts

Akshay Buch, PhD

study chair · Aerpio Therapeutics

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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