A single-center, open-label, fixed-sequence Phase 1 trial to evaluate the effect of multiple doses of pritelivir on the pharmacokinetics of substrates for CYP2C9, CYP2B6, CYP3A4 and OATP2B1

Completed

• Conditions: Herpes Simplex Virus; HSV; 10047438

• Registration Number: NL-OMON50697
• Lead Sponsor: AiCuris Anti-infective Cures AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- Subject has been informed both verbally and in writing about the objectives
of the clinical trial, the methods, and the potential risks and the discomfort
to which he/she may be exposed and has given written consent to participation
in the trial prior to trial start and any trial related procedure.
- Healthy male and female subjects of any ethnic origin, aged between 18 and 55
years (inclusive). Assessed as healthy based on a pre-trial examination
including medical history,
physical examination, blood pressure, pulse rate, body temperature, ECG
assessment, and clinical laboratory results.
- In women negative serum β-HCG (beta-human chorionic gonadotropin) test at
screening and
negative urine β-HCG test on Day -1.
- Subject agrees to pharmacogenetic blood sampling.
- Normal body weight as evidenced by a Body Mass Index (BMI) >=18.0 and <=30.0
kg/m2, and a body weight >=50.0 kg at Screening.
More criteria apply

Exclusion Criteria

1. History or current evidence of clinically relevant allergies or idiosyncrasy
to drugs or food.
2. History of allergic reactions to any active or inactive ingredient(s) of the
Investigational Medicinal Products (IMPs).
3. History or current evidence of any clinically relevant cardiovascular,
pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological,
metabolic, neurological, psychiatric, or other disease suspected to influence
pharmacokinetics or safety of the IMPs.
4. History of malignancy within 5 years, unless one of the following, treated
and considered cured: basal cell carcinoma, in situ cervical cancer, or breast
ductal carcinoma in situ.
5. Resting pulse rate after 5 minutes in supine position at Screening and Day
-1: <45 or >100 beats per minute (bpm), if out of range, up to one repeat
assessment is allowed.
More criteria apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* AUC0-*, AUC0-last, Cmax of celiprolol, flurbiprofen, bupropion and midazolam<br /><br>• Hydroxy-bupropion to bupropion AUC0-* and AUC0-last ratios and<br /><br>hydroxy-flurbiprofen to flurbiprofen AUC0-* and AUC0-last ratios </p><br>