A Study of LY2157299 Monohydrate in Healthy Volunteers

Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01746004

Enrollment

Registered

2012-12-10

Start date

2013-01-31

Completion date

2013-02-28

Last updated

2013-02-15

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

Conditions

Healthy Volunteers

Brief summary

This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.

Interventions

DRUG[^14C]-LY2157299

\[\^14C\]-LY2157299 monohydrate administered as oral solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy surgically sterile females, postmenopausal females, or sterile males * Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2) * Have venous access sufficient to allow for blood sampling

Exclusion criteria

* Have known allergies to LY2157299, related compounds or any components of the formulation * Have an abnormal blood pressure as determined by the investigator * Have participated in a \[\^14C\]-study within the last 6 months prior to admission for this study

Design outcomes

Primary

Measure	Time frame
Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Pre-dose through Day 15

Secondary

Measure	Time frame
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)	Pre-dose through Day 14
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)	Pre-dose through Day 14
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)	Pre-dose through Day 14
Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces	Pre-dose through Day 14
Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma	Pre-dose through Day 14

Countries

United States

Outcome results

None listed

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