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.

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. - Effect of acid reducing agents on PK of PQR309.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43263

Enrollment

Registered

2016-09-13

Start date

2016-07-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Group 1: Treatment A: 80 mg PQR309 once Treatment B: 300 mg ranitidine once a day for 4 days, 300 mg ranitidine once, 80 mg PQR309 once Treatment C: 150 mg ranitidine twicel, per day for 4 days, 80

Cancer

PQR309

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To assess the effect of acid reducing agents given either concomitantly or staggered on the pharmacokinetics (PK) of PQR309 following oral administration.	—

Secondary

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

Measure

Time frame

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

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)