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

Sitagliptin Combo Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: JNJ-38431055; Drug: Sitagliptin 100 mg; Drug: JNJ-38431055 + Sitagliptin 100 mg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose	Drug: JNJ-38431055; Liquid suspension of JNJ-38431055 administered as a single dose
Active Comparator: 002; Sitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose	Drug: Sitagliptin 100 mg; Capsule containing 100 mg of sitagliptin administered as a single dose
Experimental: 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	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
Placebo Comparator: 004; Placebo Placebo suspension and placebo capsule administered as single doses	Drug: Placebo; Placebo suspension and placebo capsule administered as single doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GLP-1 levels after a standard meal	0-4 hours after the standard meal

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the pharmacokinetics of JNJ-38431055 administered alone and in combination with sitagliptin.	24 hours after dosing
Assess the effect of JNJ-38431055 on appetite and satiety using a visual analogue scale (VAS)	Within 24 hours of dosing
Assess the safety and tolerability of JNJ-38431055 administered alone and in combination with sitagliptin as measured by occurrence of adverse events, ECGs, vital signs, and safety laboratory measurements.	From screening visit through follow-up visit
Assess incremental glucose changes after a meal tolerance test (MTT)	0-4 hours after MTT

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: January 15, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): September 4, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: CR016348