NCT01919684

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LGD-6972 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

Double-blind, Placebo-controlled, Randomized, Ascending Single Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LGD-6972 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Ligand Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety and tolerability of a range of single oral doses of LGD-6972 in healthy subjects. Additionally, the study will characterize the Pharmacokinetic profile in healthy subjects under fed and fasted conditions and in subjects with Type 2 Diabetes Mellitus under fasted conditions.

Detailed description

This is a double-blind, placebo-controlled, randomized, sequential, ascending, single oral dose study conducted in 2 parts. Part 1 will consist of evaluation of LGD-6972 in healthy subjects (6 groups of 8 subjects each),and will be followed by Part 2, evaluation of LGD-6972 in subjects with T2DM (1 group of 8 subjects). There will be a Screening Period of up to 30 days. Subjects who qualify for Group G (T2DM) will discontinue any anti-diabetic medication on Day -9 (1 week prior to confinement) for that group. 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. Groups of 8 subjects will be randomized in a double-blind manner to receive either LGD-6972 or placebo (6 active:2 placebo) as a single dose. Group D will receive treatment under fasted and fed conditions separated by a washout period of at least 14 days and up to 21 days. 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. After the follow up evaluation for each subject and evaluation of all safety and tolerability data, and any available PK data, the dose for the next group of subjects will be determined by the Safety Monitoring Panel (SMP).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	LGD-6972
DRUG	Placebo (Captisol®)

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2013-08-09
• Last updated: 2014-09-25

Locations

1 site across 1 country: United States