A Study of LY2140023 in Healthy Males and Females

NCT01591330 | Completed Phase 1 Results

• 2 other identifiers: 12857H8Y-MC-HBCY
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the effect of different particle size of LY2140023. The study involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a washout period of at least 3 days between doses. This study will last approximately 60 days not including screening. Screening is required within 30 days prior to study entry.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2140023

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Last Time Point of Measurable Concentration (AUC[0-tlast]) of LY2140023

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Maximum Concentration (Cmax) of LY404039 (Active Moiety)

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Last Time Point of Measurable Concentration (AUC[0-tlast]) of LY404039 (Active Moiety)

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

Secondary Outcomes (8)

• Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2140023

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Terminal Half Life (t1/2) of LY2140023

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Apparent Total Body Clearance (CL/F) of LY2140023

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Volume of Distribution During the Terminal Phase (Vz/F) of LY2140023

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

• Pharmacokinetics: Time of Maximum Observed Drug Concentrations (Tmax) of LY404039 (Active Moiety)

  Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose

Study Arms (4)

LY2140023 Reference Form

EXPERIMENTAL

LY2140023: 80 mg, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period.

Drug: LY2140023 Reference form

LY2140023 Test-Low

EXPERIMENTAL

LY2140023: 80 mg, low particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period.

Drug: LY2140023 Test-Low

LY2140023 Test-Medium

EXPERIMENTAL

LY2140023: 80 mg, medium particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period.

Drug: LY2140023 Test-Medium

LY2140023 Test-High

EXPERIMENTAL

LY2140023: 80 mg, high particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period.

Drug: LY2140023 Test-High

Interventions

LY2140023 Reference form DRUG

80-mg tablet administered orally

Also known as: LY2140023 Monohydrate (Reference)

LY2140023 Reference Form

LY2140023 Test-Low DRUG

80-mg tablet administered orally

Also known as: LY2140023 Monohydrate (Test - Low)

LY2140023 Test-Low

LY2140023 Test-Medium DRUG

80-mg tablet administered orally

Also known as: LY2140023 Monohydrate (Test - Medium)

LY2140023 Test-Medium

LY2140023 Test-High DRUG

80-mg tablet administered orally

Also known as: LY2140023 Monohydrate (Test - High)

LY2140023 Test-High

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are overtly healthy males or females, as determined by medical history and physical examination
• male participants: agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023 and agree not to donate sperm for 3 months following the last dose of LY2140023
• female participants:
• female participants of child-bearing potential who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last dose of LY2140023
• female participants who are of non-childbearing potential (that is, postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or confirmed tubal occlusion \[not tubal ligation\]). Postmenopausal is defined as no menses for at least 1 year, or a plasma follicle stimulating hormone (FSH) value of \>40 milli-international units per liter (mIU/mL), unless the participant is taking hormone replacement therapy
• have a body mass index (BMI) of 19 to 32 kilograms per meter squared (kg/m\^2), inclusive, at the time of screening
• have clinical laboratory test results within normal reference ranges for the population or investigator site or results with acceptable deviations that are judged to be not clinically significant by the investigator
• have venous access sufficient to allow for blood sampling as per the protocol
• are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• have given written informed consent approved by Lilly and the chosen ethical review board (ERB)

You may not qualify if:

• are currently enrolled in or have completed or discontinued within the last 90 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• have known allergies to LY2140023, LY404039, related compounds, or any components of the formulation
• are persons who have previously completed or withdrawn from this study or any other study investigating LY2140023 and have previously received the investigational product
• have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• have an abnormal blood pressure or pulse rate as determined by the investigator
• have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• have evidence or any history of significant active neuropsychiatric disease
• have increased risk of seizures based on a history of:
• one or more seizures (except for a single simple febrile seizure \[lacking focality and lasting less than 15 minutes, not associated with a central nervous system (CNS) infection or severe metabolic disturbance\] as a child between ages 6 months to 5 years)
• head trauma with loss of consciousness or a post-concussive syndrome within 1 year or lifetime history of head trauma with persistent neurological deficit (focal or diffuse)
• uncontrolled migraine or transient ischemic attack (TIA) within 1 year and/or stroke with persistent neurological deficit (focal or diffuse); uncontrolled migraine is defined as migraine attacks that produce headache lasting up to 72 hours and are often accompanied by associated symptoms (nausea, photophobia, and phonophobia) that impair well-being and disrupt social functioning; TIA is defined as "mini-stroke" caused by temporary disturbance of blood supply to an area of the brain, which results in a sudden, brief decrease in brain function
• CNS infection with persistent neurological deficit (focal or diffuse)
• brain surgery
• electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank seizures, spike-wave complexes, or sharp-slow wave complexes, or as locally defined)
• brain structural lesion, including developmental abnormalities, as determined by examination or imaging studies (except hydrocephalus treated by shunt or without neurological deficits).

Sponsors & Collaborators

• Denovo Biopharma LLC: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leeds, West Yorkshire, United Kingdom

Location

MeSH Terms

Interventions

pomaglumetad methionil

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 21, 2021
• Results First Posted: September 21, 2021

Record last verified: 2012-07

Locations

GB (1)