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NCT03112148 · ClinicalTrials.gov registry record · Phase 1

PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT03112148 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 24 participants.

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The verdict

NCT03112148, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.

Interventions

  • DRUG 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-09-11
Est. Completion 2017-11-15
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT03112148

The ClinicalTrials.gov registry entry for NCT03112148 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution is the first listed.

NCT03112148 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03112148 about?

NCT03112148 is a clinical study titled "PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations". This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food...

What is the current status of trial NCT03112148?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-09-11. Estimated completion is 2017-11-15.

What interventions are being tested in trial NCT03112148?

The interventions under investigation include: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution (DRUG).

Who is sponsoring clinical trial NCT03112148?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

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

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.