Last updated: January 12, 2021
Sponsor: Theravance Biopharma
Overall Status: Completed
Phase
1
Condition
Colic
Ulcerative Colitis
Crohn's Disease (Pediatric)
Treatment
N/AClinical Study ID
NCT03555617
0174
Ages 19-55 All Genders Accepts Healthy Volunteers
Study Summary
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 StatesSite Not Available

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