| Trial ID: | L4542 |
| Source ID: | NCT01054118
|
| Associated Drug: |
Jnj-38431055
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: JNJ-38431055|DRUG: Sitagliptin 100 mg|DRUG: JNJ-38431055 + Sitagliptin 100 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: GLP-1 levels after a standard meal, 0-4 hours after the standard meal | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-12
|
| Completion Date: |
2010-02
|
| Results First Posted: |
|
| Last Update Posted: |
2013-09-04
|
| Locations: |
Lincoln, Nebraska, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01054118
|
