Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study

Completed · Phase 1

Conditions studied: Inflammatory Bowel Disease

In brief

This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.

Key facts

Study ID

NCT03555617

Run by

Theravance Biopharma

People needed

36

Starts

2018-06-13

Expected to finish

2018-07-15

Last updated by the study team

2021-01-14

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 to 55 years old
• Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
• Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
• Body Mass Index (BMI) 18 to 32 kg/m2
• Willing and able to give informed consent
• Additional inclusion criteria apply

You may not qualify if…

• Planning to conceive a child during the study or within 2 months after the last dose of study drug
• Is positive for hepatitis A, B or C, and/or HIV
• Has clinically significant abnormalities in baseline laboratory evaluations
• Subject has a clinically significant abnormal electrocardiogram (ECG)
• Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)
• Additional exclusion criteria apply

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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