ClinicalTrials.Veeva

Menu

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

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo
Drug: JNJ-38431055 + Sitagliptin 100 mg
Drug: Sitagliptin 100 mg
Drug: JNJ-38431055

Study type

Interventional

Funder types

Industry

Identifiers

NCT01054118
CR016348

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

18 participants in 4 patient groups, including a placebo group

001
Experimental group
Description:
JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose
Treatment:
Drug: JNJ-38431055
002
Active Comparator group
Description:
Sitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose
Treatment:
Drug: Sitagliptin 100 mg
003
Experimental group
Description:
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
Treatment:
Drug: JNJ-38431055 + Sitagliptin 100 mg
004
Placebo Comparator group
Description:
Placebo Placebo suspension and placebo capsule administered as single doses
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems