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Completed

NCT Number: NCT02365571

A Study of LY3154207 in Healthy Participants

This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.

Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.

Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.

Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.

Participants may only enroll in 1 of the 3 parts of the study.

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Key information

Conditions

Healthy Participants

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overtly healthy males or females, as determined by medical history and physical examination
  • Female participants not of child-bearing potential
  • 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
  • Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)

Exclusion criteria

  • Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
  • Part C only: Have known allergy or contraindications to itraconazole

Treatment and study plan

LY3154207

Drug

Administered orally

Placebo

Drug

Administered orally

Itraconazole

Drug

Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution

Primary outcomes

  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: Up to 48 hours after administration of study drug

Secondary outcomes

  1. Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207

    Time frame: Predose through 48 hours after administration of study drug

  2. Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207

    Time frame: Predose through 48 hours after administration of study drug

  3. Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207

    Time frame: Predose through 48 hours after administration of study drug

  4. Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207

    Time frame: Predose through 48 hours after administration of study drug

  5. Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole

    Time frame: Predose through 96 hours after administration of study drug

  6. Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole

    Time frame: Predose through 96 hours after administration of study drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Cytochrome P450 Interaction Study of LY3154207 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2015
Registry last updated
Jun 11, 2015

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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