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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

NCT ID: NCT01054118

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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This is a double-blind (neither physician or volunteer knows the name of the assigned study drug), placebo controlled (substance containing no medication), study in healthy, overweight or obese adult male volunteers. For each volunteer, the study consists of a screening phase (up to 30 days), a treatment phase during which volunteers will receive 4 study treatments in a randomized (study sequence assigned by chance) sequence (28 days), and a follow-up phase (10 days). During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be the effect of JNJ-38431055 and sitagliptin on glucagon like peptide-1 (GLP-1) levels. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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001

JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose

Group Type EXPERIMENTAL

JNJ-38431055

Intervention Type DRUG

Liquid suspension of JNJ-38431055 administered as a single dose

002

Sitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose

Group Type ACTIVE_COMPARATOR

Sitagliptin 100 mg

Intervention Type DRUG

Capsule containing 100 mg of sitagliptin administered as a single dose

003

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

Group Type EXPERIMENTAL

JNJ-38431055 + Sitagliptin 100 mg

Intervention Type DRUG

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

004

Placebo Placebo suspension and placebo capsule administered as single doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo suspension and placebo capsule administered as single doses

Interventions

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JNJ-38431055

Liquid suspension of JNJ-38431055 administered as a single dose

Intervention Type DRUG

Sitagliptin 100 mg

Capsule containing 100 mg of sitagliptin administered as a single dose

Intervention Type 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

Intervention Type DRUG

Placebo

Placebo suspension and placebo capsule administered as single doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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CR016348

Identifier Type: -

Identifier Source: org_study_id