Phase 1
Completed N=16
A Study of Evacetrapib and Digoxin in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01897493 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin — 1.75; 2.15 nanograms/milliliter (ng/mL)
Summary
The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin |
1.75; 2.15 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin |
31.3; 33.5 | — |
| PRIMARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin |
2.00; 2.00 | — |
| SECONDARY Renal Clearance (CLr) of Digoxin |
9.43; 8.10 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy males and females (of non-childbearing potential)
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
- Normal renal function
Exclusion Criteria
- Participants who currently smoke or use tobacco or nicotine products
Data sourced from ClinicalTrials.gov (NCT01897493). 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.