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The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects
The study was conducted in 2 parts:
Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6), enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.
Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7), enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once daily for 28 days with LB54640 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB54640 | Experimental | 5 mg, 25 mg and 200 mg strengths Subjects will be administered once daily and duration vary per each cohorts. Single Ascending Dose (SAD) cohorts : 1 day
healthy Multiple Ascending Dose (MAD) cohorts: 28days
|
|
| Placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB64640 | Drug | The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Number of subjects who experienced adverse events and severity of adverse events | Through study completion upto 6weeks depending on cohorts |
| Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD) | Number of subjects who experienced adverse events of special interest (AESIs) | Through study completion upto 6weeks depending on cohorts |
| Change from baseline in vital signs (blood pressure) | Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed | Through study completion upto 6weeks depending on cohorts |
| Change from baseline in vital signs (heart rate) | Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader)) | Through study completion upto 6weeks depending on cohorts |
| Change from baseline in vital signs (weight in kilograms, height in meters) | weight and height will be combined to report BMI in kg/m^2 | Through study completion upto 6weeks depending on cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profiles in Plasma for single ascending dose cohort | Peak Plasma Concentration (Cmax) during the dosing periods | Through study completion upto 1week |
| Pharmacokinetics profiles in Plasma for single ascending dose cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of food by Pharmacokinetics profiles | Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity) | Through study completion upto 1week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Mirza | Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit | Chula Vista | California | 91911 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects
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Double blind, there will be unblinded pharmacist for investigational product distribution.
| Placebo | Drug | Placebo is provided as a matching placebo |
|
Area under the plasma concentration versus time curve (AUC)
| Upto 1week |
| Pharmacokinetics profiles in Plasma for single ascending dose cohort | Terminal half-life (t1/2) | Through study completion upto 1week during the single ascending dose cohort |
| Pharmacokinetics profiles in urine for single ascending dose cohort | Renal clearance (CLR) | upto 1week |
| Pharmacokinetics profiles in urine for single ascending dose cohort | Amount of unchanged drug excreted into urine (Ae) for specific collection intervals | Through study completion upto 1week depending on cohorts |
| Pharmacokinetics profiles in plasma for multiple ascending dose cohort | Maximum concentration (Cmax) | upto 2weeks |
| Pharmacokinetics profiles in plasma for multiple ascending dose cohort | Area under the concentration-time curve (AUC) during the dosing periods | Through study completion upto 2weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |