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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01054118

Run by

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

People needed

18

Starts

2009-12-01

Expected to finish

2010-02-01

Last updated by the study team

2013-09-04

Who can join

Age: 19 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) between 27.0 and 38.0 kg/m2 (inclusive)
• Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests
• Men must agree to use a double barrier method of birth control (e.g., condom for them and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication

You may not qualify if…

• History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
• Smoker or tobacco user within the past 6 months
• History of recent major surgery (within 6 months of study start)
• Positive test for alcohol and/or drugs of abuse
• Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
• Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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