Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 19 - 55 |
| Updated: | 9/12/2018 |
| Start Date: | June 13, 2018 |
| End Date: | July 15, 2018 |
A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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