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A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323334
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 23, 2014
Last Update Posted Date February 26, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline to Study Completion (up to 14 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
  • Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626 [ Time Frame: Day 1 or Day 14, Predose up to 120 hours after drug administration ]
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3202626 [ Time Frame: Day 1 or Day 14, Predose up to 120 hours after drug administration ]
  • Pharmacodynamic Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration [ Time Frame: Parts A, C and D: Day 1 or Day 14, Predose up to 120 hours after drug administration ]
  • Pharmacodynamic Biomarker: Cerebrospinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration [ Time Frame: Part B: Predose up to 36 hours after drug administration ]
  • Pharmacokinetics (PK): Cerebrospinal fluid (CSF) Concentration of LY3202626 [ Time Frame: Parts C and D: Day 15 after drug administration ]
  • Pharmacodynamic Biomarker: Change in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration [ Time Frame: Parts C and D: Predose up to Day 15 after drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
Official Title  ICMJE Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626
Brief Summary This study involves single and multiple doses of LY3202626 and will evaluate the effects of LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single increasing doses of LY3202626 will be given in capsule form. Part A will also include itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days with the study drug. Part C will last approximately 11-14 weeks. Part D will last approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may only enroll in one part.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy Volunteers
  • Alzheimer Disease
Intervention  ICMJE
  • Drug: LY3202626
    administered orally
  • Drug: Placebo (Part A, B, C)
    administered orally
  • Drug: Itraconazole
    administered orally
Study Arms  ICMJE
  • Experimental: LY3202626 Part A
    Single doses of LY3202626 given orally in capsule form administered up to once in each of 4 periods in a crossover fashion. Some participants may also receive multiple doses of 200 mg of Itraconazole orally in 1 period.
    Interventions:
    • Drug: LY3202626
    • Drug: Itraconazole
  • Experimental: LY3202626 Part B Low dose
    Single oral dose of LY3202626 in capsule form. Dose determined by Part A.
    Intervention: Drug: LY3202626
  • Experimental: LY3202626 Part B Mid dose
    Single oral dose of LY3202626 in capsule form. Dose determined by Part A.
    Intervention: Drug: LY3202626
  • Experimental: LY3202626 Part B High Dose
    Single oral dose of LY3202626 in capsule form. Dose determined by Part A.
    Intervention: Drug: LY3202626
  • Experimental: LY3202626 Part C Low dose
    Multiple oral doses of LY3202626 in capsule form. Drug is given once daily, for 14 days. Dose determined by Part B.
    Intervention: Drug: LY3202626
  • Experimental: LY3202626 Part C Mid dose
    Multiple oral doses of LY3202626 in capsule form. Drug is given once daily for 14 days. Dose determined by Part B.
    Intervention: Drug: LY3202626
  • Experimental: LY3202626 Part C High dose
    Multiple oral doses of LY3202626 in capsule form. Drug is given once daily for 14 days. Dose determined by Part B.
    Intervention: Drug: LY3202626
  • Experimental: LY3202626 Part D
    Multiple oral doses of LY3202626 in capsule form. Drug is given once daily for 14 days. Dose determined by Part B.
    Intervention: Drug: LY3202626
  • Placebo Comparator: Placebo Part A
    Single oral dose of placebo given in capsule form.
    Intervention: Drug: Placebo (Part A, B, C)
  • Placebo Comparator: Placebo Part B
    Single oral dose of placebo given in capsule form.
    Intervention: Drug: Placebo (Part A, B, C)
  • Placebo Comparator: Placebo Part C
    Multiple oral doses of placebo given in capsule form. Placebo is given once daily for 14 days.
    Intervention: Drug: Placebo (Part A, B, C)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2016)
136
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2014)
100
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • For Parts A, B, and C, are overtly healthy males or females (nonchildbearing potential), as determined by medical history and physical examination
  • Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)
  • For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild to moderate AD
  • Have venous access sufficient to allow for blood sampling
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

  • Taking over-the-counter or prescription medication with the exception of vitamins or minerals
  • Smoke more than 10 cigarettes per day
  • Are unwilling or unable to refrain from eating any food or drinking any beverage containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose until completion of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02323334
Other Study ID Numbers  ICMJE 15562
I7X-EW-LLCA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP