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Bipolar DisorderPhase 1NCT01383967

A Study of LY2979165 in Healthy Subjects

A Phase 1 study testing LY2979165 in people with Bipolar Disorder, run by Eli Lilly and Company at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder
What is being tested?
LY2979165
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteSingapore
Study dates
Jul 2011to Jun 2012
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

  • 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

Who cannot join

  • 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 all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • 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

Other trials in Singapore

About this study

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

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.

Being tested
LY2979165, placebo
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2979165Drug

    Administered orally

  • placeboDrug

    Administered orally

Study groups in NCT01383967
Study groupRoleWhat they receive
LY2979165 Part A, Cohort 1Experimental20 mg LY2979165 administered orally, daily for 14 days
Receives: Drug: LY2979165
LY2979165 Part A, Cohort 2Experimental60 mg LY2979165 administered orally, daily for 14 days
Receives: Drug: LY2979165
LY2979165 Part A, Cohort 3Experimental100 mg LY2979165 administered, orally daily for 14 days
Receives: Drug: LY2979165
LY2979165 Part A, Cohort 4Experimental150 mg LY2979165 administered orally, daily for 14 days
Receives: Drug: LY2979165
LY2979165 Part B, Cohort 5ExperimentalDose to be determined by safety review of doses administered in Part A, administered, orally daily for 14 days
Receives: Drug: LY2979165
PlaceboPlacebo comparatorAdministered orally, daily for 14 days in a ratio of 3:1 in each Cohort of Part A
Receives: Drug: placebo
LY2979165 Part A, Cohort 6Experimental250 mg LY2979165 administered orally, daily for 14 days
Receives: Drug: LY2979165
LY2979165 Part A, Cohort 7Experimental400 mg LY2979165 administered orally, daily for 14 days
Receives: Drug: LY2979165

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with clinically significant effects

    Measured: Baseline to study completion (estimate of 5 months, study ran for 11 months)

Secondary outcomes (6)

  1. Pharmacokinetics, area under the concentration curve (AUC): Part A

    Measured: 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

  2. Pharmacokinetics, maximum concentration (Cmax): Part A

    Measured: 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

  3. Pharmacokinetics, area under the concentration curve (AUC): Part B

    Measured: 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

  4. Pharmacokinetics, maximum concentration (Cmax): Part B

    Measured: 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

  5. Pharmacokinetics; maximum concentration (Cmax) for Cerebrospinal Fluid (CSF): Part B

    Measured: Pre dose (baseline) and 9 hours post dose

  6. Pharmacodynamics; maximum concentration (Cmax) for CSF: Part B

    Measured: Pre dose (baseline) and 9 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01383967
Sponsor's protocol ID
13846
Other IDs
I4S-EW-HHCB
Status last verified
Jun 2012
First submitted
27 Jun 2011
Last updated
14 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2979165 in people with Bipolar Disorder, run by Eli Lilly and Company at 1 site in Singapore.

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 8 inclusion and 23 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 14 Jun 2012. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?

Number of participants with clinically significant effects (time frame: Baseline to study completion (estimate of 5 months, study ran for 11 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01383967.

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 14 Jun 2012.

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