NL-OMON51382
Completed
Not Applicable
A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Assess the Effect of Multiple Doses of Oral THB001 on the Pharmacokinetics of Oral Caffeine, Omeprazole, and Midazolam (CYP1A2, CYP2C19 and CYP3A4 probe substrates) in Healthy Volunteers - CS0376-210320
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- allergic mediated diseases
- Sponsor
- Third Harmonic Bio
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent in accordance with local regulations before the
- •conduct of any study\-related procedures.
- •2\. Healthy as determined by the Investigator, based on a medical evaluation
- •including medical history, physical examination, laboratory tests and ECG
- •recording. A subject with a clinical abnormality or laboratory parameters
- •outside the reference range for the population being studied may be included
- •only if, in the opinion of the Investigator, the finding is (a) unlikely to
- •introduce additional risk to the subject, (b) will not interfere with study
- •procedures or confound study results, and (c) is not otherwise exclusionary
Exclusion Criteria
- •1\. A positive urine drug screen/alcohol breath test at Screening or Day \-1\.
- •2\. A positive Hepatitis B surface antigen or positive Hepatitis C antibody
- •result at screening.
- •3\. A positive test for human immunodeficiency virus (HIV) antibody at screening.
- •4\. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin
- •levels greater than the upper limit of normal (ULN) at Screening or Day \-1\. One
- •test result up to 1\.25 x the ULN is allowed. One retest at Screening and on Day
- •\-1 is allowed. Subjects with Gilbert\*s Syndrome are permitted to have total
- •bilirubin values outside the 1\.25 x the ULN, as judged by the Investigator as
- •long as the AST and ALT are within normal limits (WNL).
Outcomes
Primary Outcomes
Not specified
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