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Clinical Trial Details

Trial ID: L5180
Source ID: NCT01919684
Associated Drug: Lgd-6972
Title: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LGD-6972 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: LGD-6972|DRUG: Placebo (Captisol®)
Outcome Measures: Primary: Safety and tolerability of single oral doses of LGD-6972 in healthy subjects and in subjects with T2DM., Subjects in Groups A,B,C,D,E and F will be admitted to the study site on Day -1, and Group G will be admitted to the study site on Day -2. Each subject will be administered a specified dose of LGD-6972 or placebo under fasting conditions (and fed conditions for Group D to evaluate the effects of food on the LGD-6972 PK profile)and will be observed through the morning of Day 3 (48 hour post dose assessment). Safety assessments, LGD-6972 PK sample collection, and PD assessments will occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation., Subjects observed through the morning of Day 3 (48 hour post dose assessment). Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation.. | Secondary: Pharmacokinetic (PK) profile of LGD-6972 and its potential metabolites after a single oral dose in healthy subjects and in subjects with T2DM., Subjects in Groups A,B,C,D,E and F will be admitted to the study site on Day -1, and Group G will be admitted to the study site on Day -2. Each subject will be administered a specified dose of LGD-6972 or placebo under fasting conditions (and fed conditions for Group D to evaluate the effects of food on the LGD-6972 PK profile)and will be observed through the morning of Day 3 (48 hour post dose assessment). Safety assessments, LGD-6972 PK sample collection, and PD assessments will occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation., Subjects observed through the morning of Day 3 (48 hour post dose assessment). Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation..|Pharmacodynamic (PD) profile of LGD-6972 after a single oral dose in healthy subjects and in subjects with T2DM., Subjects in Groups A,B,C,D,E and F will be admitted to the study site on Day -1, and Group G will be admitted to the study site on Day -2. Each subject will be administered a specified dose of LGD-6972 or placebo under fasting conditions (and fed conditions for Group D to evaluate the effects of food on the LGD-6972 PK profile)and will be observed through the morning of Day 3 (48 hour post dose assessment). Safety assessments, LGD-6972 PK sample collection, and PD assessments will occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation., Subjects observed through the morning of Day 3 (48 hour post dose assessment). Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation..|The effect of food on the bioavailability and PK profile of LGD-6972 and its potential metabolites after a single oral 40 mg dose in healthy subjects., Subjects in Groups A,B,C,D,E and F will be admitted to the study site on Day -1, and Group G will be admitted to the study site on Day -2. Each subject will be administered a specified dose of LGD-6972 or placebo under fasting conditions (and fed conditions for Group D to evaluate the effects of food on the LGD-6972 PK profile)and will be observed through the morning of Day 3 (48 hour post dose assessment). Safety assessments, LGD-6972 PK sample collection, and PD assessments will occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation., Subjects observed through the morning of Day 3 (48 hour post dose assessment). Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation..
Sponsor/Collaborators: Sponsor: Ligand Pharmaceuticals | Collaborators: Beckloff Associates, Inc.|Medpace, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-11
Completion Date: 2014-03
Results First Posted:
Last Update Posted: 2014-09-25
Locations: Medpace Clinical Pharmacology, Cincinnati, Ohio, 45227, United States
URL: https://clinicaltrials.gov/show/NCT01919684