A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers

NCT01248052 | Completed Phase 1

• 2 other identifiers: 13844I4S-EW-HHCA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two part study (Parts A and B), the purpose of which is to determine the safety of LY2979165 in healthy people, and any side effects that might be associated with it, and to understand how the body handles LY2979165. In addition, Part B, will also look at levels of LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Number of participants with clinically significant effects

  predose through 48 hours postdose

Secondary Outcomes (4)

• Pharmacokinetics, area under the concentration curve (AUC), Parts A and B

  predose through 48 hours postdose

• Pharmacokinetics maximum plasma concentration (Cmax), Parts A and B.

  predose through 48 hours post dose

• Pharmacokinetics, cerebrospinal fluid area under the concentration curve (AUC), Part B only

  predose through 48 hours postdose

• Pharmacokinetics, maximum cerebrospinal fluid concentration (Cmax), Part B only

  predose through 48 hours postdose

Study Arms (5)

LY2979165 (Part A)

EXPERIMENTAL

single oral doses at dose levels ranging from 20 to 1000 mg

Drug: LY2979165

Placebo (Part A)

PLACEBO COMPARATOR

single oral dose

Drug: Placebo

LY2979165 - low dose (Part B)

EXPERIMENTAL

single oral low dose of LY297165 (dose to be determined by Part A)

Drug: LY2979165

LY2979165 - high dose (Part B)

EXPERIMENTAL

single oral high dose of LY2979165 (dose determined from Part A)

Drug: LY2979165

Placebo - Part B

PLACEBO COMPARATOR

single oral dose

Drug: Placebo

Interventions

LY2979165 DRUG

administered orally

LY2979165 (Part A); LY2979165 - high dose (Part B); LY2979165 - low dose (Part B)

Placebo DRUG

administered orally

Placebo (Part A); Placebo - Part B

Eligibility Criteria

• Age: 21 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. Female subjects in Part B are at the site's discretion.
• Male subjects: Agree to use a reliable method of birth control during the study.
• Female subjects: Women not of child-bearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age greater than or equal to 45 years with an intact uterus, who have not taken hormones or oral contraceptives for \> 1 year, and either:
• spontaneous amenorrhea of \>12 months, or
• spontaneous amenorrhea of 6-12 months with a follicle- stimulating hormone (FSH) level of \>40 mIU/mL
• Are between the body mass index (BMI) of 18.5 and 29.9 kg/m2, inclusive.
• Have clinical laboratory test results within normal reference range 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 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 ethical review board governing the site.

You may not qualify if:

• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, other than the study drug/device used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Are persons who have previously completed or withdrawn from this study.
• History of clinically significant adverse drug reactions or "drug allergy" to more than 3 different types of systemically administered medications or known allergies to LY2979165 or it's constituents.
• Have a Bazett's corrected QT (QTcB) interval value of \>450 msec (males) or \>470 msec (females) or any abnormality in the screening 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
• Have an abnormal blood pressure (at least 5 minutes in supine position) as determined by the investigator.
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, immunological, 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 increased risk of seizures as evidenced by a history of: greater than or equal to 1 seizure (except childhood febrile seizure), history of electroencephalogram with epileptiform activity, history of stroke, surgery to the cerebral cortex, or head trauma with loss of consciousness.
• Show evidence of significant active neuropsychiatric disease.
• Have a history of alcohol or drug abuse.
• Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
• Have donated blood of more than 450 mL within the last 3 months prior to dosing.
• Subjects who meet at least 1 of the following criteria (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits):
• subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females),
• subjects unwilling to stop alcohol consumption 48 hours prior to dosing until the completion of each study appointment, or

Sponsors & Collaborators

• Eli Lilly and Company: 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

Singapore, Singapore

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

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

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

SG (1)