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NCT01458054 · ClinicalTrials.gov registry record · Phase 1

Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT01458054 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants.

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The verdict

NCT01458054, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.

Interventions

  • DRUG Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)
  • DRUG Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2011-09-27
Est. Completion 2011-11-28
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01458054

The ClinicalTrials.gov registry entry for NCT01458054 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) is the first listed.

NCT01458054 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01458054 about?

NCT01458054 is a clinical study titled "Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults". This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.

What is the current status of trial NCT01458054?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-09-27. Estimated completion is 2011-11-28.

What interventions are being tested in trial NCT01458054?

The interventions under investigation include: Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) (DRUG), Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) (DRUG).

Who is sponsoring clinical trial NCT01458054?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

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

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