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A Comparison Study of the Bioavailability of a Capsule Formulation of LGD-6972 to an Oral Solution Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672839
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Ligand Pharmaceuticals

Brief Summary:
The purpose of this study is to compare relative oral bioavailability of a capsule formulation of LGD-6972 to a solution formulation of LGD-6972.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: LGD-6972 Solution Drug: LGD-6972 Capsules Phase 1

Detailed Description:

This is a single center, randomized, open-label, single dose study conducted in a 2-way crossover design.

A total of 8 subjects will be enrolled in the study. The duration of participation for each subject will be approximately 36 days, not including a Screening Period of up to 30 days.

Each treatment period, subjects will be admitted to the study site on Day -1 and observed through the morning of Day 3 (48-hour post-dose assessment). Over 2 treatment periods, subjects will receive each of the following treatments as a single dose orally, under fasting conditions, per the randomization (4 subjects per treatment in each treatment period:

Treatment A - 15 mg of LGD-6972 as capsules

Treatment B - 15 mg LGD-6972 as solution

Serial blood samples will be collected through 48 hours following each dose to determine the concentration of LGD 6972 in plasma. Safety assessments will also occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Days 4, 7, and 14 for follow up procedures. Subjects will return to the study site for the second treatment period after an additional 7 days. Subjects will be discharged from the study after returning to the study site on Day 14 of the second treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Open-Label, 2-Period Complete Crossover Study to Compare the Bioavailability of a Capsule Formulation of LGD-6972 to an Oral Solution Formulation in Healthy Adult Subjects
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Period 1 Treatment A
Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted
Drug: LGD-6972 Capsules
15 mg LGD-6972
Other Name: LGD-6972 Sodium Salt Capsules

Experimental: Period 1 Treatment B
Healthy subjects will receive a single dose orally of LGD-6972 solution fasted
Drug: LGD-6972 Solution
15 mg of LGD-6972
Other Name: LGD-6972 Sodium Salt in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF)

Experimental: Period 2 Treatment A
Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted
Drug: LGD-6972 Capsules
15 mg LGD-6972
Other Name: LGD-6972 Sodium Salt Capsules

Experimental: Period 2 Treatment B
Healthy subjects will receive a single dose orally of LGD-6972 solution fasted
Drug: LGD-6972 Solution
15 mg of LGD-6972
Other Name: LGD-6972 Sodium Salt in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF)




Primary Outcome Measures :
  1. Pharmacokinetics Analysis- Area Under the Concentration Curve (AUC) [ Time Frame: Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose ]
    AUC: ratio: medium test form to reference form

  2. Pharmacokinetics Analysis- Maximum Concentration (Cmax) [ Time Frame: Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose ]
    Cmax: ratio: medium test form to reference form


Secondary Outcome Measures :
  1. Severity of all Adverse Events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Day -1, 24, 48, 72hrs, and 7day and 14day post dose ]
    The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 14 days post-dose



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile (hysterectomy or bilateral oophorectomy or bilateral tubal ligation), or naturally post menopausal for at least 12 months and with a follicle stimulating hormone (FSH) level in the post-menopausal range (if not taking hormone replacement therapy) to be considered for enrollment
  2. Willing and able to provide written informed consent
  3. Not diabetic and has a fasting blood glucose between 70 and 105 mg/dL, inclusive
  4. In good health with no significant concomitant pathology based on medical history, physical examination, ECG, routine laboratory tests (chemistry, hematology, lipid profile, and urinalysis), and vital signs
  5. Has a body mass index (BMI) between 18.5 kg/m2 and 30 kg/m2, inclusive, and must weigh more than 45 kg
  6. Male subjects must either have a vasectomy or agree that they and any female partners will use 2 acceptable forms of contraception, one of which must be a condom, until 30 days after the last dose of study drug. Other acceptable forms of contraception include hormonal contraceptives, intrauterine device, Depo Provera®, Norplant® System Implants, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, and contraceptive sponge, foam, or jelly.

Exclusion Criteria:

  1. History of drug and/or alcohol abuse within 2 years prior to screening
  2. Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions outlined in the protocol
  3. Unwilling to comply with restrictions on strenuous exercise as specified in the protocol
  4. Has a history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data
  5. Has liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) 10% of the upper limit of normal (ULN), or has creatine kinase (CK) levels 2 × ULN at screening or admission to site (Day 1). Abnormal values at screening may be retested once
  6. Has a serum triglyceride level 400 mg/dL at screening. If the triglyceride level is between 400 mg/dL and 500 mg/dL, one retest is permitted
  7. Recent history of uncontrolled high blood pressure or has systolic blood pressure 90 mmHg or 140 mmHg or diastolic blood pressure 50 mmHg or 90 mmHg at screening. One or more retests of blood pressure within a reasonable period of time are permissible at the discretion of the Investigator
  8. Is taking prescription or non-prescription drugs other than those outlined in the protocol
  9. Has a positive screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV)
  10. Woman of childbearing potential
  11. Lactating or has a positive pregnancy test
  12. Has donated 450 mL of blood within 56 days of admission to the investigational site or has donated blood products within 30 days of admission.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672839


Locations
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United States, Ohio
Medpace, Inc
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Ligand Pharmaceuticals
Medpace, Inc.
Investigators
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Principal Investigator: Lukasz Biernat, M.D. Medpace Clinical Pharmacology
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Responsible Party: Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02672839    
Other Study ID Numbers: L6972-03
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Betadex
Sequestering Agents
Molecular Mechanisms of Pharmacological Action