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NCT01967771 · ClinicalTrials.gov registry record · Phase 1

Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects

A Phase 1 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01967771 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 16 participants.

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The verdict

NCT01967771, a Phase 1 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There is no washout between treatment periods.

Interventions

  • DRUG DTG
  • DRUG CBZ

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2013-10
Est. Completion 2014-01
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

What the Registry Record Tells You About NCT01967771

The ClinicalTrials.gov registry entry for NCT01967771 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which DTG is the first listed.

NCT01967771 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01967771 about?

NCT01967771 is a clinical study titled "Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects". This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the ...

What is the current status of trial NCT01967771?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-10. Estimated completion is 2014-01.

What interventions are being tested in trial NCT01967771?

The interventions under investigation include: DTG (DRUG), CBZ (DRUG).

Who is sponsoring clinical trial NCT01967771?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.