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Drug-Drug Interaction (DDI) Study for TD-9855

NCT03432793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-01-14

No results posted yet for this study

Summary

This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.

Conditions

  • Drug Drug Interaction (DDI)

Interventions

DRUG

TD-9855

oral tablet, QD

DRUG

Fluvoxamine

oral tablet, QD

DRUG

Itraconazole

oral tablet solution, QD

DRUG

Caffeine

oral solution, single dose

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2018-04-21
Completion
2018-04-21
FDA Drug
Yes

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 NCT03432793 on ClinicalTrials.gov