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Also known as JNJ-38431055 Dose 1
JNJ-38431055 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose |
| 002 | ACTIVE_COMPARATOR | Sitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose |
| 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 |
| 004 | PLACEBO_COMPARATOR | Placebo Placebo suspension and placebo capsule administered as single doses |
| Name | Type | Description |
|---|---|---|
| JNJ-38431055 | DRUG | Liquid suspension of JNJ-38431055 administered as a single dose |
| Sitagliptin 100 mg | DRUG | Capsule containing 100 mg of sitagliptin administered as a single dose |
| 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 |
| Placebo | DRUG | Placebo suspension and placebo capsule administered as single doses |
| JNJ-38431055 Dose 1 | DRUG | Liquid suspension/solution of JNJ-38431055 administered as a single dose |
| JNJ-38431055 Dose 2 | DRUG | Liquid suspension/solution of JNJ-38431055 administered as a single dose |
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 fo...
JNJ-38431055 is an investigational small molecule developed by Johnson & Johnson for the treatment of type 2 diabetes mellitus. It has been studied in Phase 1 clinical trials in healthy male volunteers and in volunteers with type 2 diabetes, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics.
JNJ-38431055 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored all three Phase 1 trials of the compound in type 2 diabetes mellitus.
JNJ-38431055 is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three are listed as completed. No later-phase trials of JNJ-38431055 are registered.
JNJ-38431055 has been studied in three completed Phase 1 trials: NCT01054118, which tested single doses of JNJ-38431055, sitagliptin, and their co-administration; NCT00910923 in healthy male volunteers; and NCT00871507 in volunteers with type 2 diabetes mellitus.
Yes. JNJ-38431055 Dose 1 is an alternative name used for JNJ-38431055, the investigational small molecule developed by Johnson & Johnson for type 2 diabetes mellitus. Both names refer to the same compound.
Across its three completed Phase 1 trials, JNJ-38431055 enrolled a total of 80 participants. The studies were randomized, double-blind, and placebo-controlled, with enrollment of 18, 37, and 25 participants respectively.