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

Last updated: January 12, 2021
Sponsor: Theravance Biopharma
Overall Status: Completed

Phase

1

Condition

Colic

Ulcerative Colitis

Crohn's Disease (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03555617
0174
  • Ages 19-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female between 18 to 55 years old
  • Male subjects must abstain from sexual intercourse or use a highly effective method ofbirth control
  • Women of child bearing potential must have a negative pregnancy test and eitherabstain 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

Exclusion

Exclusion Criteria:

  • Planning to conceive a child during the study or within 2 months after the last doseof 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 aninvestigational drug (or medical device)
  • Additional exclusion criteria apply

Study Design

Total Participants: 36
Study Start date:
June 13, 2018
Estimated Completion Date:
July 15, 2018

Connect with a study center

  • Celerion

    Lincoln, Nebraska 68502
    United States

    Site Not Available

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