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A Study of LY3045697 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01750853
First received: December 13, 2012
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to investigate the safety and tolerability of LY3045697 after a single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups) of 9 participants each will participate in 3 dosing periods. These participants will receive placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and placebo by the end of both periods.


Condition Intervention Phase
Healthy Volunteers
Drug: LY3045697
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3045697 After Single Oral Dosing in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline to 10 Days Post Dose (Estimated up to 8 Weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3045697 [ Time Frame: Baseline to 72 Hours Post Dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) from Zero to Infinity (AUC 0-∞) of LY3045697 [ Time Frame: Baseline to 72 Hours Post Dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1

Period 1: 0.1 milligrams (mg) LY3045697 administered once orally or matching placebo administered once orally.

Period 2: 1 mg LY3045697 administered once orally or matching placebo administered once orally.

Period 3: 10 mg LY3045697 administered once orally or matching placebo administered once orally.

Drug: LY3045697
Administered orally
Drug: Placebo
Administered orally
Experimental: Group 2

Period 1: 0.3 mg LY3045697 administered once orally or matching placebo administered once orally.

Period 2: 3 mg LY3045697 administered once orally or matching placebo administered once orally.

Period 3: 30 mg LY3045697 administered once orally or matching placebo administered once orally.

Drug: LY3045697
Administered orally
Drug: Placebo
Administered orally
Experimental: Group 3

Period 1: 100 mg of LY3045697 administered once orally or matching placebo administered once orally.

Period 2: 300 mg of LY3045697 administered once orally or matching placebo administered once orally (via split delivery over a 15-minute period).

Drug: LY3045697
Administered orally
Drug: Placebo
Administered orally

Detailed Description:

Cohort 3 added per protocol amendment (April, 2013).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are healthy males or females of non-child bearing potential as determined by medical history and physical examination
  • Male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days after the end of the final dosing
  • Female participants must be postmenopausal or surgically sterile
  • Postmenopausal female participants are between the ages of 45 and 65 years, inclusive and must be 12 months without a menstrual period or 6-12 months without a menstrual period and Follicle-Stimulating Hormone (FSH) greater than (>) 40 International Units per Liter (IU/L)
  • Have a body mass index (BMI) between 18.0 and 32.5 kilogram per square meter (kg/m²), inclusive, at entry
  • 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 Medical Investigator (MI)
  • Have venous access sufficient to allow blood sampling
  • Are non-smokers or smoker of 5 or less cigarettes/cigars/pipes per day as determined by history
  • Have the ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), poppy seed, and tobacco products from 48 hours prior to entry in the clinical research center until discharge

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 60 days prior to drug administration inclusive from a clinical trial involving an investigational drug that has not received regulatory approval for any indication
  • Have previously completed or withdrawn from this study or any other study investigating this study drug
  • Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the MI, indicates a medical problem that would preclude study participation
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the MI, increases the risks associated with participating in the study. In addition, participants with the following findings will be excluded:
  • Confirmed corrected QT (QTcF) interval > 450 milliseconds (msec) for males and > 470 msec for females; additional ECGs may be performed if required
  • Complete bundle branch blocks and other conduction abnormalities other than mild first degree atrio-ventricular block
  • Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
  • History of unexplained syncope
  • Family history of unexplained sudden death or sudden death due to long QT syndrome
  • T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the MI
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen (HBsAg)
  • Intend to use over-the-counter or prescription medication within 5 days prior to dosing, other than daily multi-vitamin therapy, stable thyroid hormone replacement or medication assessed as acceptable by the MI and not interfering with the integrity of the study data collection. Medications for benign indications in healthy participants may be continued, with the exception of drugs that may alter adrenal function, blood pressure or potassium
  • Have donated blood of more than 50 milliliters (mL) of blood within 60 days prior to dosing
  • Have an average weekly alcohol intake that exceeds 21 units per week or participants unwilling to stop alcohol within 48 hours of entry into study until discharge each period (1 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)
  • Have an abnormal blood pressure (supine) defined as diastolic blood pressure >95 or less than (<) 50 millimeters of mercury (mmHg) and/or systolic blood pressure >150 or <90 mmHg confirmed by at least 1 repeat measurement
  • Regularly use known drugs of abuse or show positive findings for such use on urinary drug screening
  • Use of natural licorice (glycyrrhizinic acid) within 5 days of enrollment or use during the study
  • Are unwilling to abstain from using grapefruit-containing products and salt-substitutes containing potassium for the duration of the study
  • Have serum potassium >upper limit of normal (result from suspected hemolyzed sample may be repeated) or <lower limit of normal per lab reference range
  • Have serum creatinine >124 micromoles per liter (μmol/L) (male); >106 μmol/L (female)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750853

Locations
Netherlands
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.
Zuidlaren, Netherlands
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: NCT01750853     History of Changes
Other Study ID Numbers: 15035, I6S-MC-ASEA, 2012-004968-22
Study First Received: December 13, 2012
Last Updated: July 25, 2013
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

ClinicalTrials.gov processed this record on November 25, 2014