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 | Completed Phase 1

• 1 other identifier: CR016348
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• GLP-1 levels after a standard meal

  0-4 hours after the standard meal

Secondary Outcomes (4)

• 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

Study Arms (4)

001

EXPERIMENTAL

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

Drug: JNJ-38431055

002

ACTIVE COMPARATOR

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

Drug: Sitagliptin 100 mg

003

EXPERIMENTAL

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

004

PLACEBO COMPARATOR

Placebo Placebo suspension and placebo capsule administered as single doses

Drug: Placebo

Interventions

JNJ-38431055 DRUG

Liquid suspension of JNJ-38431055 administered as a single dose

001

Sitagliptin 100 mg DRUG

Capsule containing 100 mg of sitagliptin administered as a single dose

002

JNJ-38431055 + Sitagliptin 100 mg DRUG

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

003

Placebo DRUG

Placebo suspension and placebo capsule administered as single doses

004

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 22, 2010
• Study Start: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

US (1)