A Multiple Dose Study of LY3023703 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Celecoxib; Drug: LY3023703; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01849055

14708

I6H-MC-MCBB (Other Identifier)

Details and patient eligibility

About

This is a study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream and how long it takes the body to remove the study drug. The effects of LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any side effects that occur will be collected. The study is expected to last 21 weeks.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy individuals based on the history and physical examinations as determined by the investigator
• Are normotensive (defined as supine systolic blood pressure [BP] less than 140 millimeters of mercury [mm Hg] and diastolic BP less than 90 mm Hg without the use of any antihypertensives) or results that are judged to be not clinically significant by the investigator

Exclusion criteria

• Have presence of clinically significant active bleeding or history of bleeding diathesis at the time of screening
• Have presence of active peptic ulcer disease, gastro-intestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, or chronic diarrhea
• Have evidence of other chronic liver disease
• Have any use of nonsteroidal anti-inflammatory drugs (NSAIDs), celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per day [g/day] within 14 days of admission
• Have greater than 1 plus pretibial pitting edema or 2 plus ankle or pedal edema

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matching LY3023703 administered orally, once daily (QD), for 28 days

Treatment:

Drug: Placebo

LY3023703

Experimental group

Description:

Escalating doses (2.5 milligram \[mg\] up to 30 mg) of LY3023703 administered orally, QD, for 28 days

Treatment:

Drug: LY3023703

Celecoxib

Active Comparator group

Description:

400 mg celecoxib administered orally, QD, for 28 days. (Positive control.)

Treatment:

Drug: Celecoxib