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A Study of LY3050258 in Healthy Participants

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Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Placebo
Drug: LY3050258

Study type

Interventional

Funder types

Industry

Identifiers

NCT01929707
14935
I6R-MC-DLAA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.

Enrollment

38 patients

Sex

All

Ages

30 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males or healthy postmenopausal females, including Japanese participants
  • Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)

Exclusion criteria

  • An abnormal sitting blood pressure as determined by the investigator
  • Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
  • Current use of statins within the last 3 months prior to dosing
  • Current or previous use of anabolic steroids in the preceding 6 months prior to dosing
  • Use of dehydroepiandrosterone, other potential over-the-counter (OTC) steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

38 participants in 2 patient groups, including a placebo group

LY3050258
Experimental group
Description:
Single escalating dose of LY3050258 (2 milligram \[mg\] up to 200 mg) administered in up to two of two periods.
Treatment:
Drug: LY3050258
Placebo
Placebo Comparator group
Description:
Single dose of placebo matching LY3050258 administered in up to one of two periods.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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