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A Study of LY2979165 in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of LY2979165 in Healthy Subjects

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Multiple-Ascending Doses of LY2979165 in Healthy Subjects

NCT01383967•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This is a two part study. Part A is a multiple-ascending dose study in up to 6 different groups of healthy subjects, with approximately 12 subjects in each of the groups. Part A will allow investigation of up to 6 different doses of LY2979165. The drug will be administered for a total of 14 days. Subjects will be resident in the clinical research unit (CRU) from Day -1 (the day before dosing) until Day 15. Part B will investigate a dose of LY2979165 previously administered in Part A in up to 12 subjects. The drug will be administered for a total of 14 days. In addition to the same assessments as would have been completed in Part A, subjects in Part B will also have cerebrospinal fluid samples taken from the lower lumbar region of their spine.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Are overtly healthy males or females, as determined by medical history and physical examination. Female subjects for Part B (if performed) 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, not taken hormones or oral contraceptives for \> 1 year, and either: Spontaneous amenorrhoea of \>12 months, or Spontaneous amenorrhoea 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/m\^2, 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 (ERB) governing the site

Exclusion Criteria

•Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product 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
•History of clinically significant adverse drug reactions or "drug allergy" to more than 3 different types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose) or known allergies to LY2979165 or it's constituents
•Are persons who have previously completed or withdrawn from this study or any other study investigating LY2979165
•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
•Show evidence of significant active neuropsychiatric disease
•Have increased risk of seizures as evidenced by a history of: greater than or equal to one (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
•Have a history of alcohol or drug abuse
•Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
+13 more criteria

Locations (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

Key Dates

Start Date

July 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

June 14, 2012

Enrollment

102

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

LY2979165

DRUG

placebo

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY2979165 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder