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A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211

NCT01568411 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-22

No results posted yet for this study

Summary

This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4) and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg tablet of TD- 1211 administered orally to fasted subjects.

Conditions

  • Healthy

Interventions

DRUG

TD-1211

Period 1

DRUG

TD-1211+ itraconazole

Period 2

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Glycyx Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568411 on ClinicalTrials.gov