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Trial record 5 of 5 for:    LY3202626

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

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Alzheimer Disease Drug: LY3202626 Drug: Placebo (Part A, B, C) Drug: Itraconazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: LY3202626
administered orally

Drug: Itraconazole
administered orally

Experimental: LY3202626 Part B Low dose
Single oral dose of LY3202626 in capsule form. Dose determined by Part A.
Drug: LY3202626
administered orally

Experimental: LY3202626 Part B Mid dose
Single oral dose of LY3202626 in capsule form. Dose determined by Part A.
Drug: LY3202626
administered orally

Experimental: LY3202626 Part B High Dose
Single oral dose of LY3202626 in capsule form. Dose determined by Part A.
Drug: LY3202626
administered orally

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.
Drug: LY3202626
administered orally

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.
Drug: LY3202626
administered orally

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.
Drug: LY3202626
administered orally

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.
Drug: LY3202626
administered orally

Placebo Comparator: Placebo Part A
Single oral dose of placebo given in capsule form.
Drug: Placebo (Part A, B, C)
administered orally

Placebo Comparator: Placebo Part B
Single oral dose of placebo given in capsule form.
Drug: Placebo (Part A, B, C)
administered orally

Placebo Comparator: Placebo Part C
Multiple oral doses of placebo given in capsule form. Placebo is given once daily for 14 days.
Drug: Placebo (Part A, B, C)
administered orally




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626 [ Time Frame: Day 1 or Day 14, Predose up to 120 hours after drug administration ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Pharmacokinetics (PK): Cerebrospinal fluid (CSF) Concentration of LY3202626 [ Time Frame: Parts C and D: Day 15 after drug administration ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323334


Locations
United States, California
California Clinical Trials Medical Group
Glendale, California, United States, 91206
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02323334     History of Changes
Other Study ID Numbers: 15562
I7X-EW-LLCA ( Other Identifier: Eli Lilly and Company )
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors