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A Study of LY3006072 in Healthy Participants

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Status and phase

Terminated
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo
Drug: LY3006072

Study type

Interventional

Funder types

Industry

Identifiers

NCT01640249
I6B-MC-HZBA (Other Identifier)
14372

Details and patient eligibility

About

The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.

This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

Full description

This study has two parts:

Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).

Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Overtly healthy males or females, as determined by medical history and physical examination
  • Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug
  • Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause
  • Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m^2), inclusive

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

18 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning.
Treatment:
Drug: Placebo
LY3006072
Experimental group
Description:
Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg.
Treatment:
Drug: LY3006072

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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