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Completed

NCT Number: NCT01372085

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

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

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-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (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.

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Key information

Conditions

Healthy Participants

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male participants:

  • 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 participants:

  • 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.

All participants:

  • have a screening body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (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, participants 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

All participants:

  • 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. Participants 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 electrocardiogram (ECG) [including but not limited to Bazett's corrected QT (QTcB) interval >450 milliseconds (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 milliliters (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 [ unit = 12 ounces (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

Treatment and study plan

LY2584702 Reference Formulation

Drug

Administered orally

LY2584702 Test Formulation

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]

    The Cmax following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.

Secondary outcomes

  1. Pharmacokinetics, Area Under the Concentration-Time Curve (AUC)

    Time frame: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]

    AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)] and AUC from time 0 to infinity [AUC(0-inf)] following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.

  2. Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol)

    Time frame: Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h.

    Baseline-adjusted change-from-predose in lipid concentrations were measured to assess the LY2584702 effect on lipids under different fed states. The 50-milligram (mg) LY2584702 test formulation [TF (tablet)] was the only dose and formulation administered in both the fasted and fed states for comparison. Therefore, changes in total cholesterol after single oral doses of placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 reference formulation [RF (capsule)] were not calculated. The baseline-adjusted change-from-predose in total cholesterol levels in the fasted and fed state following a single 50-mg LY2584702 TF dose is reported. Baseline was Day -1 of Period 1 for Period 3 fasted state and baseline was Day -1 of Period 4a for Period 4a fed state. Least squares (LS) means was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, time, treatment by time, and participant.

  3. Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1

    Time frame: Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose)

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 reference formulation [RF (capsule)] were administered in a fasted state are reported at baseline (Day 1, Predose) and 3 hours (h), 4 h, 6 h, and 24 h postdose.

  4. Part B: Average Time-Matched QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1

    Time frame: Part B: Baseline [Period 1 (Day -1)] and Periods 1 to 4 (Day 1). Electrocardiograms (ECG) were performed at time point 0 and 3 h, 4 h, 6 h, and 24 h.

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 test formulation [TF (tablet)], LY2584702 reference formulation [RF (capsule)], or placebo were administered in a fasted or fed state are reported at baseline (time-matched Day -1 QTcF) and 3 hours (h), 4 h, 6 h, and 24 h postdose. Day 1, Hour 24 was time-matched with Day-1, Hour 0.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2011
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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