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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin

NCT01054118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-09-04

No results posted yet for this study

Summary

This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male volunteers.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

JNJ-38431055

Liquid suspension of JNJ-38431055 administered as a single dose

DRUG

Sitagliptin 100 mg

Capsule containing 100 mg of sitagliptin administered as a single dose

DRUG

JNJ-38431055 + Sitagliptin 100 mg

Liquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose

DRUG

Placebo

Placebo suspension and placebo capsule administered as single doses

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054118 on ClinicalTrials.gov