| Trial ID: | L5372 |
| Source ID: | NCT06615700
|
| Associated Drug: |
Na-931
|
| Title: |
Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
T2DM
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Overweight or Obesity|Type 2 Diabetes
|
| Interventions: |
DRUG: NA-931|DRUG: Placebo
|
| Outcome Measures: |
Primary: Incidence of Treatment-Emergent Adverse Events in NA-931 participants, To evaluate the safety and tolerability of NA-931, 28 days | Secondary: Maximum observe drug concentration (Cmax) of NA-931, Pharmacokinetics (PK) Cmax, 28 days|Effect of a High-Fat Meal on Plasma Concentration of NA-931, Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose, 28 days
|
| Sponsor/Collaborators: |
Sponsor: Biomed Industries, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-05-06
|
| Completion Date: |
2024-09-20
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-27
|
| Locations: |
Biomed Industries Pty Limited- Clinical Testing Site 1, Camperdown, New South Wales, 2050, Australia|Biomed Industries, Pty Limited Testing Site 2, Parkville, Victoria, 3052, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT06615700
|
