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
- Conditions
- allergic mediated diseasesallergic asthmachronic rhinosinusitisand food allergychronic idiopathic and inducible urticaria
- Registration Number
- NL-OMON51382
- Lead Sponsor
- Third Harmonic Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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
(see Exclusion Criteria).
3. Vasectomized men and women, age 18-65 years inclusive at will be enrolled.
Women of child-bearing potential must agree not to attempt to become pregnant
and to use a highly effective form of hormonal (excluding oral contraceptives)
or non-hormonal birth control, which entails the use of a non-hormonal
intra-uterine device/system in combination with a barrier method (e.g. condom,
diaphragm, cervical cap with spermicide) or abstinence during the study and for
90 days after the (last) study drug administration. Postmenopausal women must
have had >=12 months of spontaneous amenorrhea (with documented
follicle-stimulating hormone (FSH) >=30 mIU/mL). Surgically sterile women are
defined as those who have had a hysterectomy, bilateral ovariectomy, or
bilateral tubal ligation. Women who are surgically sterile must provide
documentation of the procedure by an operative report or by ultrasound. All
women must have a negative pregnancy test result on Day 1 before (first)
administration of study medication. Male subjects must have had a vasectomy at
least 4 months prior to the Screening Visit and must have a documented
post-surgical follow up to confirm success of the vasectomy. They must also
agree to use a condom from Day 1 until 90 days after the last dose of study.
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).
5. Hemoglobin, Platelet count, or White blood cell count below the lower limit
of normal LLN at Screening. Hemoglobin, Platelet count, or White blood cell
count below the LLN on Day -1. One retest is allowed at each visit.
6. Serum creatinine greater than the ULN at Screening or Day -1. One retest is
allowed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK parameters for midazolam, caffeine and omeprazole include, but are not<br /><br>limited to: Cmax, tmax, AUC0-t, and AUC0-inf.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability parameters include: physical examination, AEes,<br /><br>clinical laboratory values, vital signs and 12-lead ECGs.</p><br>