Trial · NCT01736254
A Study of Evacetrapib in Healthy Participants
NCT01736254, Phase 1, Completed, Eli Lilly and Company; results first posted 2018-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Evacetrapib in Healthy Participants. Trials, record NCT01736254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01736254
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Evacetrapib in Healthy Participants
- NCT number
- NCT01736254
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Healthy Volunteers
- Interventions
- Evacetrapib, Gemfibrozil
- First posted
- 2012-11-29
- Last updated
- 2018-10-03
- Results first posted
- 2018-10-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil. |
| Primary | Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil. |
| Primary | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil. |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib. |
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib. |
| Secondary | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Gemfibrozil | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Cmax data. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable AUCτ data. | nanograms*hours/milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Tmax data. | hours | MEDIAN |
| SECONDARY | Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable AUCτ data. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Cmax data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Gemfibrozil | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Tmax data. | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Evacetrapib | 1270 | Geometric Coefficient of Variation 26 | nanograms/milliliter (ng/mL) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Evacetrapib + Gemfibrozil | 1290 | Geometric Coefficient of Variation 26 | nanograms/milliliter (ng/mL) | |
| Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib | Evacetrapib | 11300 | Geometric Coefficient of Variation 20 | nanograms*hours/milliliter (ng*h/mL) | |
| Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib | Evacetrapib + Gemfibrozil | 11400 | Geometric Coefficient of Variation 21 | nanograms*hours/milliliter (ng*h/mL) | |
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Evacetrapib | 4.00 | Full Range 2.02 to 6.00 | hours | |
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Evacetrapib + Gemfibrozil | 3.00 | Full Range 2.00 to 4.00 | hours | |
| Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil | Gemfibrozil | 55700 | Geometric Coefficient of Variation 23 | ng*h/mL | |
| Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil | Evacetrapib + Gemfibrozil | 53800 | Geometric Coefficient of Variation 22 | ng*h/mL | |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil | Gemfibrozil | 17400 | Geometric Coefficient of Variation 32 | ng/mL | |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil | Evacetrapib + Gemfibrozil | 16800 | Geometric Coefficient of Variation 34 | ng/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Day 1) | STARTED | All Participants | 24 | |
| Period 1 (Day 1) | Received at Least One Dose of Study Drug | All Participants | 24 | |
| Period 1 (Day 1) | COMPLETED | All Participants | 24 | |
| Period 1 (Day 1) | NOT COMPLETED | All Participants | 0 | |
| Period 2 (Days 2 to 12) | STARTED | All Participants | 24 | |
| Period 2 (Days 2 to 12) | COMPLETED | All Participants | 21 | |
| Period 2 (Days 2 to 12) | NOT COMPLETED | All Participants | 3 | |
| Period 3 (Days 13 to 23) | STARTED | All Participants | 21 | |
| Period 3 (Days 13 to 23) | COMPLETED | All Participants | 20 | |
| Period 3 (Days 13 to 23) | NOT COMPLETED | All Participants | 1 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lacrimation increased | Eye disorders | Gemfibrozil | 0 | 24 | 0 |
| other | Lacrimation increased | Eye disorders | Evacetrapib | 1 | 24 | 1 |
| other | Lacrimation increased | Eye disorders | Evacetrapib + Gemfibrozil | 0 | 21 | 0 |
| other | Ocular hyperaemia | Eye disorders | Gemfibrozil | 0 | 24 | 0 |
| other | Ocular hyperaemia | Eye disorders | Evacetrapib | 0 | 24 | 0 |
| other | Ocular hyperaemia | Eye disorders | Evacetrapib + Gemfibrozil | 1 | 21 | 1 |
| other | Bowel movement irregularity | Gastrointestinal disorders | Gemfibrozil | 0 | 24 | 0 |
| other | Bowel movement irregularity | Gastrointestinal disorders | Evacetrapib | 1 | 24 | 1 |
| other | Bowel movement irregularity | Gastrointestinal disorders | Evacetrapib + Gemfibrozil | 0 | 21 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Gemfibrozil | 0 | 24 | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemfibrozil | ||
| Total, all-cause mortality | Evacetrapib | ||
| Total, all-cause mortality | Evacetrapib + Gemfibrozil | ||
| Total, other adverse events | Gemfibrozil | 1 | 24 |
| Total, other adverse events | Evacetrapib | 8 | 24 |
| Total, other adverse events | Evacetrapib + Gemfibrozil | 7 | 21 |
| Total, serious adverse events | Gemfibrozil | 0 | 24 |
| Total, serious adverse events | Evacetrapib | 0 | 24 |
| Total, serious adverse events | Evacetrapib + Gemfibrozil | 0 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01736254
GET https://conductscience.org/api/trials/v1/NCT01736254/events?page=2