Trial · NCT01812538
A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects
NCT01812538, Phase 1, Completed, Hospira, now a wholly owned subsidiary of Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects. Trials, record NCT01812538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01812538
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects
- NCT number
- NCT01812538
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 70 participants, actual
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Conditions
- Ventricular Repolarization
- Interventions
- DIC075V
- First posted
- 2013-03-18
- Last updated
- 2015-07-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-matched active drug-placebo difference in baseline-adjusted QTc interval | At -1.5, -1.0, and -0.5 hours (pre-dose), and 5, 10, 15, and 30 minutes (2-min window) and 1, 2, 4, 6, 8, 12, and 23.5 hours (5-min window) on Study Days 1, 4, 7, and 10. | The primary ECG endpoint is the time-matched active drug-placebo difference in baseline-adjusted QTc interval using the Fridericia correction formula (QTcF). The QTcF is evaluated at the time point where the maximal baseline and placebo-adjusted value is observed. These measurements are consistent with ICH E14 guidance. |
| Secondary | Time-matched active drug-placebo difference in baseline-adjusted QTc interval using the Bazett's correction formula (QTcB) evaluated at the timepoint where the maximum mean baseline- and placebo-adjusted QTcB is observed for each active treatment arm | At -1.5, -1.0, and -0.5 hours (pre-dose), and 5, 10, 15, and 30 minutes (2-min window) and 1, 2, 4, 6, 8, 12, and 23.5 hours (5-min window) on Study Days 1, 4, 7, and 10. | |
| Secondary | Time matched active drug-placebo difference in baseline adjusted QTcF at the subject-specific Tmax or the next available ECG timepoint | At -1.5, -1.0, and -0.5 hours (pre-dose), and 5, 10, 15, and 30 minutes (2-min window) and 1, 2, 4, 6, 8, 12, and 23.5 hours (5-min window) on Study Days 1, 4, 7, and 10. | |
| Secondary | Time-matched active drug-placebo difference in the maximum baseline-adjusted QTcF of each subject at each active treatment period. | At -1.5, -1.0, and -0.5 hours (pre-dose), and 5, 10, 15, and 30 minutes (2-min window) and 1, 2, 4, 6, 8, 12, and 23.5 hours (5-min window) on Study Days 1, 4, 7, and 10. | |
| Other | Maximum plasma concentration (Cmax) for diclofenac and HPβCD | At Time 0 (pre-dose), and 5, 10, 15, 20, and 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 23.5 hours after dosing on Study Days 1, 4, 7 and 10. | |
| Other | Time to Cmax (Tmax) for diclofenac and HPβCD | At Time 0 (pre-dose), and 5, 10, 15, 20, and 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 23.5 hours after dosing on Study Days 1, 4, 7 and 10. | |
| Other | Areas under the curve to the last sample with a measurable concentration [AUC(0-t)] for diclofenac and HPβCD | At Time 0 (pre-dose), and 5, 10, 15, 20, and 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 23.5 hours after dosing on Study Days 1, 4, 7 and 10. | |
| Other | Area under the curve from time 0 extrapolated to infinite time AUC(inf) for diclofenac and HPβCD | At Time 0 (pre-dose), and 5, 10, 15, 20, and 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 23.5 hours after dosing on Study Days 1, 4, 7 and 10. | |
| Other | Elimination rate constant (λz) for diclofenac and HPβCD | At Time 0 (pre-dose), and 5, 10, 15, 20, and 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 23.5 hours after dosing on Study Days 1, 4, 7 and 10. | |
| Other | Half-life (t½) for diclofenac and HPβCD | At Time 0 (pre-dose), and 5, 10, 15, 20, and 30 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 23.5 hours after dosing on Study Days 1, 4, 7 and 10. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23578606 | DERIVED |
Source PubMed
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/NCT01812538
GET https://conductscience.org/api/trials/v1/NCT01812538/registered