A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
NCT02398669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2015-11-03
Summary
Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.
Conditions
Interventions
- DRUG
-
Lorcaserin hydrochloride
A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water.
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-05-31
Countries
- United States
Study Locations
More Related Trials
-
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
NCT05694260 ·Status: COMPLETED ·Phase: PHASE2
-
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite
NCT04190654 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
NCT01594957 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Pharmacokinetics of Three QRL-101 Formulations in Healthy Participants
NCT06877624 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers
NCT03072056 ·Status: COMPLETED ·Phase: PHASE1
-
Olmesartan Pediatric Pharmacokinetic (PK) Study
NCT00151814 ·Status: COMPLETED ·Phase: PHASE1
-
PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects
NCT03942666 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
NCT01569815 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function
NCT02372084 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of CXB909 in Healthy Male Subjects
NCT01505907 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron
NCT00940121 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
NCT05599932 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Telavancin in Normal and Obese Subjects
NCT02753855 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates
NCT02211079 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers
NCT03542916 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
NCT05097716 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects
NCT02264054 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products
NCT01476683 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function
NCT00416702 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes
NCT01187862 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects
NCT07076459 ·Status: COMPLETED ·Phase: PHASE1
-
Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product Concentrations
NCT07338214 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
NCT04587622 ·Status: COMPLETED ·Phase: PHASE1
-
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
NCT01529294 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants
NCT01732237 ·Status: COMPLETED ·Phase: PHASE1