Trial · NCT07901595
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1 Part 1: Safety and tolerability of PAL-119 in healthy volunteers | 8 days | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 1 Part 2: Safety and tolerability of PAL-119 in healthy volunteers | 17 days | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 1 Part 3: Safety and tolerability of PAL-119 in healthy volunteers | 8 days | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 2 Part 4: Safety and tolerability of PAL-119 in adult participants with Type 2 diabetes | 17 weeks | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 2 Part 4: Incidence and severity of hypoglycemic episodes in adult participants with Type 2 diabetes | 17 weeks | hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors |
| Primary | Phase 2 Part 5: Safety and tolerability of PAL-119 in adult participants with Type 1 diabetes | 17 weeks | Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) |
| Primary | Phase 2 Part 5: Incidence and severity of hypoglycemic episodes in adult participants with Type 1 diabetes | 17 weeks | hypoglycemic episodes (low blood sugar below 70 mg/dL) will be evaluated using continuous glucose monitors |
| Primary | Phase 2 Part 5: Incidence and severity of diabetic ketoacidosis and episodes of hyperglycemia with ketonemia not meeting diagnostic criteria for diabetic ketoacidosis in adult participants with Type 1 diabetes | 17 weeks | Incidence of clinically diagnosed diabetic ketoacidosis during the defined time frame of study. Diabetic ketoacidosis (DKA) is a serious, life-threatening emergency that happens when your body lacks enough insulin to turn blood sugar into energy, forcing it to break down fat into toxic acids called ketones. |
| Secondary | Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-T 1/2 | 8 days | T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Secondary | Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-AUC | 8 days | The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time. |
| Secondary | Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-Tmax | 8 days | Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin |
| Secondary | Phase 1 Part 1: To characterize the PK profile of oral PAL-119 following single dose of PAL-119 in healthy volunteers-Cmax | 8 days | Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Secondary | Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-T 1/2 | 17 days | T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Secondary | Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-AUC | 17 days | The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time |
| Secondary | Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-Tmax | 17 days | Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin |
| Secondary | Phase 1 Part 2: To characterize the PK profile of oral PAL-119 following multiple doses of PAL-119 in healthy volunteers-Cmax | 17 days | Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Secondary | Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: T 1/2 | 8 days | T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Secondary | Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: AUC | 8 days | The area under the curve (AUC) measures the total systemic exposure of a drug in the body over time |
| Secondary | Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: Tmax | 8 days | Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin |
| Secondary | Phase 1 Part 3: To characterize the PK profile of oral PAL-119 following single dose administered under fed and fasted conditions in healthy volunteers: Cmax | 8 days | Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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