Type 2 Diabetes Mellitus (T2DM)Phase 1NCT02672839
A Comparison Study of the Bioavailability of a Capsule Formulation of LGD-6972 to an Oral Solution Formulation
A Phase 1 study testing LGD-6972 Solution and LGD-6972 Capsules in people with Type 2 Diabetes Mellitus (T2DM), run by Ligand Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- LGD-6972 Solution and LGD-6972 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Willing and able to provide written informed consent
- Not diabetic and has a fasting blood glucose between 70 and 105 mg/dL, inclusive
- 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
- Has a body mass index (BMI) between 18.5 kg/m2 and 30 kg/m2, inclusive, and must weigh more than 45 kg
- 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.
Who cannot join
- History of drug and/or alcohol abuse within 2 years prior to screening
- Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions outlined in the protocol
- Unwilling to comply with restrictions on strenuous exercise as specified in the protocol
- 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
- 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
- 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
Show all 12Show fewer
- 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
- Is taking prescription or non-prescription drugs other than those outlined in the protocol
- Has a positive screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV)
- Woman of childbearing potential
- Lactating or has a positive pregnancy test
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- LGD-6972 Solution, LGD-6972 Capsules
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGD-6972 SolutionDrug
Also called LGD-6972 Sodium Salt in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF)
15 mg of LGD-6972
LGD-6972 CapsulesDrug
Also called LGD-6972 Sodium Salt Capsules
15 mg LGD-6972
| Study group | Role | What they receive |
|---|---|---|
| Period 1 Treatment A | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted Receives: Drug: LGD-6972 Capsules |
| Period 1 Treatment B | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 solution fasted Receives: Drug: LGD-6972 Solution |
| Period 2 Treatment A | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted Receives: Drug: LGD-6972 Capsules |
| Period 2 Treatment B | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 solution fasted Receives: Drug: LGD-6972 Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Analysis- Area Under the Concentration Curve (AUC)
AUC: ratio: medium test form to reference form
Measured: Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose
Pharmacokinetics Analysis- Maximum Concentration (Cmax)
Cmax: ratio: medium test form to reference form
Measured: Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose
Secondary outcomes (1)
Severity of all Adverse Events graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 14 days post-dose
Measured: Day -1, 24, 48, 72hrs, and 7day and 14day post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Lukasz Biernat, M.D., Principal investigator, Medpace Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672839
- Sponsor's protocol ID
- L6972-03
- Status last verified
- Mar 2016
- First submitted
- 27 Jan 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02672839
- Acronym / sponsor ID
- L6972-03
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 Treatment A | Experimental | Drug: LGD-6972 CapsulesHealthy subjects will receive a single dose orally of LGD-6972 capsules fasted |
| Period 1 Treatment B | Experimental | Drug: LGD-6972 SolutionHealthy subjects will receive a single dose orally of LGD-6972 solution fasted |
| Period 2 Treatment A | Experimental | Drug: LGD-6972 CapsulesHealthy subjects will receive a single dose orally of LGD-6972 capsules fasted |
| Period 2 Treatment B | Experimental | Drug: LGD-6972 SolutionHealthy subjects will receive a single dose orally of LGD-6972 solution fasted |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Willing and able to provide written informed consent
- Not diabetic and has a fasting blood glucose between 70 and 105 mg/dL, inclusive
- 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
- Has a body mass index (BMI) between 18.5 kg/m2 and 30 kg/m2, inclusive, and must weigh more than 45 kg
Key exclusion criteria (12 listed)
- History of drug and/or alcohol abuse within 2 years prior to screening
- Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions outlined in the protocol
- Unwilling to comply with restrictions on strenuous exercise as specified in the protocol
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGD-6972 SolutionAlso: LGD-6972 Sodium Salt in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF)15 mg of LGD-6972 | Drug | Period 1 Treatment B, Period 2 Treatment B |
| LGD-6972 CapsulesAlso: LGD-6972 Sodium Salt Capsules15 mg LGD-6972 | Drug | Period 1 Treatment A, Period 2 Treatment A |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz Biernat, M.D. principal investigator
Medpace Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LGD-6972 Solution and LGD-6972 Capsules in people with Type 2 Diabetes Mellitus (T2DM), run by Ligand Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.