Thte effect of acid reducing agents on the single dose pharmacokinetics of PQR309 and the absolute bioavailability, safety and tolerability of PQR309 following oral and intravenous administration in healthy subjects.

Completed

• Conditions: Cancer; 10027655

• Registration Number: NL-OMON43263
• Lead Sponsor: PIQUR Therapeutics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

healthy male subjects
18 - 65 years of age, inclusive
BMI 18.0 - 30.0 kilograms/meter2
non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effect of acid reducing agents given either concomitantly or<br /><br>staggered on the pharmacokinetics (PK) of PQR309 following oral administration.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To derive primary and secondary PK parameters of PQR309 and their between<br /><br>subject variability after oral and intravenous (iv) administration in<br /><br>non-smokers and smokers.<br /><br>To evaluate the effect of CYP1A2 inhibition on the PK parameters of PQR309 in<br /><br>smokers.<br /><br>To evaluate the safety and tolerability of PQR309 following oral and iv<br /><br>administration of single doses in healthy volunteers in the absence and<br /><br>presence of acid reducing agents or a CYP1A2 inhibitor.</p><br>