Single Dose Study in Healthy Volunteers to Investigate the Safety and Absorption of LY2584702

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01372085
First received: June 2, 2011
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

This is a single-centre, placebo-controlled, two-part study in healthy subjects.

Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic (effect of drug on a biological marker-pS6 levels in skin biopsies) of a single dose of 25 mg LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.


Condition Intervention Phase
Tumors
Drug: LY2584702 Reference Formulation
Drug: LY2584702 Test Formulation
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Ascending Dose and Relative Bioavailability Study of LY2584702 in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: maximum observed plasma concentration (Cmax) [ Time Frame: Predose and up to 48 hours post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Predose and up to 48 hours post dose ] [ Designated as safety issue: Yes ]
  • Change from baseline in the concentration of lipids [ Time Frame: Baseline and up to 24 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: 25 mg RF
A single 25 mg dose of LY2548702 Reference Formulation (RF)
Drug: LY2584702 Reference Formulation
Administered orally
Placebo Comparator: Part A: Placebo
Placebo taken orally
Drug: Placebo
Administered orally
Experimental: Part B: Sequence 1
A single 10 mg dose of LY2548702 Test Formulation (TF) during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Drug: LY2584702 Test Formulation
Administered orally
Drug: Placebo
Administered orally
Experimental: Part B: Sequence 2
Placebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Drug: LY2584702 Reference Formulation
Administered orally
Drug: LY2584702 Test Formulation
Administered orally
Drug: Placebo
Administered orally
Experimental: Part B: Sequence 3
A single 10 mg dose of LY2548702 Test Formulation (TF) during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Drug: LY2584702 Test Formulation
Administered orally
Drug: Placebo
Administered orally
Experimental: Part B: Sequence 4
A single 10 mg dose of LY2548702 Test Formulation (TF) during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Drug: LY2584702 Test Formulation
Administered orally
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372085

Locations
Singapore
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01372085     History of Changes
Other Study ID Numbers: 14318, I3G-FW-JGCE
Study First Received: June 2, 2011
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 23, 2014