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A Single Ascending Dose and Relative Bioavailability Study of LY2584702 in Healthy Subjects

Phase 1
21 Years
65 Years
Not Enrolling

Thank you

Trial Information

A Single Ascending Dose and Relative Bioavailability Study of LY2584702 in Healthy Subjects

Inclusion Criteria:

Male subjects:

Agree to use a reliable method of birth control during the study and for at least 1 month
following the last dose of study drug

Female subjects:

Women not of childbearing potential due to surgical sterilization (hysterectomy or
bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are
deemed postmenopausal if they are greater than or equal to 45 years old, who have not
taken hormones or oral contraceptives within the last year, and had cessation of menses
for at least 1 year, or who have had 6 to 12 months of amenorrhea with
follicle-stimulating hormone (FSH) levels consistent with postmenopausal state.

- have a screening body mass index of 18.5 to 32.0 kg/m^2, inclusive

- have clinical laboratory test results within the normal range for the population or
investigator site, or with abnormalities deemed clinically insignificant by the
investigator. In particular, subjects should have normal or near normal screening
liver tests at the discretion of the investigator

- have normal blood pressure and pulse rate (supine) at screening, or with minor
deviations judged to be acceptable 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. Subjects that participate in Part A of this study may participate in Part
B of the study if the first dosing in Part B is >30 days after the dose of LY2584702
or placebo in Part A.

- have known allergies to LY2584702, or related compounds

- have an abnormality in the 12-lead ECG (including but not limited to Bazett's
corrected QT [QTcB] interval >450 msec for men and >470 msec for women)

- have a history within the last 2 years 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 a history of drug or alcohol abuse, or regularly use known drugs of abuse

- show evidence of human immunodeficiency virus infection and/or positive human
immunodeficiency virus (HIV) antibodies

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

- intend to use over-the-counter or prescription medication within 14 days prior to
dosing or during the study

- use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice,
Seville oranges, or Starfruit within 7 days prior to study dosing or intended use
during the study

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

- have an average weekly alcohol intake that exceeds 21 units per week (males) and 14
units per week (females), or are unwilling to stop alcohol consumption from prior to
dosing until the completion of each study period (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)

Applicable for Part A only:

• have known allergies to lignocaine, adrenaline, tetracycline, or related compounds,
which will be used in the skin biopsy procedure

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics: maximum observed plasma concentration (Cmax)

Outcome Time Frame:

Predose and up to 48 hours post dose

Safety Issue:


Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

September 2011

Related Keywords:

  • Tumors