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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02858271

Enrollment

Registered

2016-08-08

Start date

2016-07-31

Completion date

2016-07-31

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGAKB-9778 subcutaneous injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI 18 - 33 kg/m2

Exclusion criteria

* Significant cardiovascular, pulmonary, or renal disease

Design outcomes

Primary

Measure	Time frame
Elimination rate of AKB-9778 and any major metabolites identified	7 days
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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026