A Study of LY2979165 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01383967
• Date of registration: 27/06/2011
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of LY2979165 in Healthy Subjects
• Scientific title: Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Multiple-Ascending Doses of LY2979165 in Healthy Subjects
• Date of first enrolment: July 2011
• Target sample size: 102
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01383967
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Singapore

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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

- Show evidence of hepatitis B and/or positive hepatitis B surface antigen

- Intended use of over-the-counter medication within 7 days prior to dosing or during
the study with the exception of vitamins and mineral supplements (not providing >100%
of the recommended dietary allowance [RDA]), or occasional paracetamol or
acetaminophen. If this situation arises, inclusion of an otherwise suitable subject
may be at the discretion of the sponsor.

- Intended use of herbal supplements or prescription medications, other than stable
doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or
during the study. If this situation arises, inclusion of an otherwise suitable
subject may be at the discretion of the sponsor.

- Have donated blood of more than 450 mL within the last 3 months

- 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): a) subjects who
have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
units per week (females), b) subjects unwilling to stop alcohol consumption 48 hours
prior to dosing until the completion of the 14-day dosing period, or c) subjects
unwilling to limit alcohol intake to no more than 3 units per day at other times
during the study.

- Cigarette consumption of more than 10 cigarettes per day or unable/unwilling to abide
by CRU smoking restrictions during admissions

- Any other condition, which in the opinion of the investigator, would preclude
participation in the study

Additional criteria for Part B:

- Abnormalities in lumbar spine previously known or determined by screening lumbar
x-ray (if conducted).

- History of clinically significant back pain, back pathology and/or back injury (for
example, degenerative disease, spinal deformity or spinal surgery) that may
predispose to complications or technical difficulty with lumbar puncture

- Have evidence or history of significant active bleeding or coagulation disorder or
have taken non-steroidal anti inflammatory drugs or other drugs that affect
coagulation or platelet function within 14 days prior to lumbar catheter insertion

- Have an allergy to lidocaine (Xylocaine®) or its derivatives

- Have medical or surgical conditions in which lumbar puncture is contraindicated



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Intervention(s)

Drug: LY2979165

Drug: placebo

Primary Outcome(s)

Number of participants with clinically significant effects [Time Frame: Baseline to study completion (estimate of 5 months, study ran for 11 months)]

Secondary Outcome(s)

Pharmacodynamics; maximum concentration (Cmax) for CSF: Part B [Time Frame: Pre dose (baseline) and 9 hours post dose]

Pharmacokinetics, area under the concentration curve (AUC): Part A [Time Frame: predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose, up to 24 hours on day 7, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose,up to 48 hours on and after day 14]

Pharmacokinetics, area under the concentration curve (AUC): Part B [Time Frame: predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14]

Pharmacokinetics, maximum concentration (Cmax): Part A [Time Frame: predose, up 24 hours on day 1, predose and 4 hours on day 3, predose, up to 24 hours on day 7, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14]

Pharmacokinetics, maximum concentration (Cmax): Part B [Time Frame: predose, up to 24 hours on day 1, predose and 4 hours on day 3, predose day 8, predose and 4 hours on day 10, predose day 12 and 13 and predose, up to 48 hours on and after day 14]

Pharmacokinetics; maximum concentration (Cmax) for Cerebrospinal Fluid (CSF): Part B [Time Frame: Pre dose (baseline) and 9 hours post dose]

Secondary ID(s)

13846

I4S-EW-HHCB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors