Trial · NCT01836198
The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
NCT01836198, Phase 1, Completed, Eli Lilly and Company; results first posted 2019-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream. Trials, record NCT01836198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01836198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
- NCT number
- NCT01836198
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Healthy Volunteers
- Interventions
- LY2409021, Gemfibrozil, Ketoconazole, Clarithromycin
- First posted
- 2013-04-19
- Last updated
- 2019-03-08
- Results first posted
- 2019-03-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) | |
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) | All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data. | nanogram*hours per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) | All participants who received at least 1 dose of study drug and had evaluable Cmax data. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
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: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | LY2409021 Only (Part A, Cohort 1) | 34700 | Geometric Coefficient of Variation 31 | nanogram*hours per milliliter (ng*h/mL) | |
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | LY2409021+Gemfibrozil (Part A, Cohort 1) | 35300 | Geometric Coefficient of Variation 35 | nanogram*hours per milliliter (ng*h/mL) | |
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | LY2409021 Only (Part A, Cohort 2) | 38000 | Geometric Coefficient of Variation 21 | nanogram*hours per milliliter (ng*h/mL) | |
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | LY2409021+Ketoconazole (Part A, Cohort 2) | 145000 | Geometric Coefficient of Variation 23 | nanogram*hours per milliliter (ng*h/mL) | |
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | LY2409021 Only (Part B Participants, Data From Part A) | 37400 | Geometric Coefficient of Variation 25 | nanogram*hours per milliliter (ng*h/mL) | |
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | LY2409021+Clarithromycin (Part B) | 43900 | Geometric Coefficient of Variation 28 | nanogram*hours per milliliter (ng*h/mL) | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | LY2409021 Only (Part A, Cohort 1) | 431 | Geometric Coefficient of Variation 23 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | LY2409021+Gemfibrozil (Part A, Cohort 1) | 410 | Geometric Coefficient of Variation 18 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | LY2409021 Only (Part A, Cohort 2) | 445 | Geometric Coefficient of Variation 19 | nanograms per milliliter (ng/mL) | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | LY2409021+Ketoconazole (Part A, Cohort 2) | 471 | Geometric Coefficient of Variation 19 | nanograms per milliliter (ng/mL) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A, Period 1 | STARTED | Part A: LY2409021+Gemfibrozil (Cohort 1) | 15 | |
| Part A, Period 1 | STARTED | Part A: LY2409021+Ketoconazole (Cohort 2) | 15 | |
| Part A, Period 1 | STARTED | Part B: LY2409021+Clarithromycin | 0 | |
| Part A, Period 1 | Received at Least 1 Dose of Study Drug | Part A: LY2409021+Gemfibrozil (Cohort 1) | 15 | |
| Part A, Period 1 | Received at Least 1 Dose of Study Drug | Part A: LY2409021+Ketoconazole (Cohort 2) | 15 | |
| Part A, Period 1 | Received at Least 1 Dose of Study Drug | Part B: LY2409021+Clarithromycin | 0 | |
| Part A, Period 1 | COMPLETED | Part A: LY2409021+Gemfibrozil (Cohort 1) | 15 | |
| Part A, Period 1 | COMPLETED | Part A: LY2409021+Ketoconazole (Cohort 2) | 15 | |
| Part A, Period 1 | COMPLETED | Part B: LY2409021+Clarithromycin | 0 | |
| Part A, Period 1 | NOT COMPLETED | Part A: LY2409021+Gemfibrozil (Cohort 1) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events232
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 | Dry eye | Eye disorders | LY2409021 Only (Part A, Cohort 1) | 0 | 15 | 0 |
| other | Dry eye | Eye disorders | Gemfibrozil Only (Part A, Cohort 1) | 0 | 15 | 0 |
| other | Dry eye | Eye disorders | LY2409021+Gemfibrozil (Part A, Cohort 1) | 0 | 15 | 0 |
| other | Dry eye | Eye disorders | LY2409021 Only (Part A, Cohort 2) | 0 | 15 | 0 |
| other | Dry eye | Eye disorders | Ketoconazole Only (Part A, Cohort 2) | 0 | 15 | 0 |
| other | Dry eye | Eye disorders | LY2409021+Ketoconazole (Part A, Cohort 2) | 1 | 15 | 1 |
| other | Dry eye | Eye disorders | Clarithromycin Only (Part B) | 0 | 12 | 0 |
| other | Dry eye | Eye disorders | LY2409021+Clarithromycin (Part B) | 0 | 12 | 0 |
| other | Eye irritation | Eye disorders | LY2409021 Only (Part A, Cohort 1) | 0 | 15 | 0 |
| other | Eye irritation | Eye disorders | Gemfibrozil Only (Part A, Cohort 1) | 1 | 15 | 1 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2409021 Only (Part A, Cohort 1) | ||
| Total, all-cause mortality | Gemfibrozil Only (Part A, Cohort 1) | ||
| Total, all-cause mortality | LY2409021+Gemfibrozil (Part A, Cohort 1) | ||
| Total, all-cause mortality | LY2409021 Only (Part A, Cohort 2) | ||
| Total, all-cause mortality | Ketoconazole Only (Part A, Cohort 2) | ||
| Total, all-cause mortality | LY2409021+Ketoconazole (Part A, Cohort 2) | ||
| Total, all-cause mortality | Clarithromycin Only (Part B) | ||
| Total, all-cause mortality | LY2409021+Clarithromycin (Part B) | ||
| Total, other adverse events | LY2409021 Only (Part A, Cohort 1) | 6 | 15 |
| Total, other adverse events | Gemfibrozil Only (Part A, Cohort 1) | 1 | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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/NCT01836198
GET https://conductscience.org/api/trials/v1/NCT01836198/flow?page=2