Phase 1
Completed N=48
A Multiple Dose Study of LY3023703 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01849055 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703 |
332; 1140; 2300; 5290; 300; 1340 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703 |
42.6; 126; 228; 556; 41.9; 151 | — |
| SECONDARY Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703 |
2.01; 3.00; 4.00; 4.00; 2.00; 2.00 | — |
| SECONDARY Change From Baseline to Day 27 in Blood Pressure (BP) |
-1.45; -2.67; -2.54; -2.99; -2.98; -5.29 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01849055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.