The influence of pancreatic function on the pharmacokinetics of ivacaftor in patients with cystic fibrosis

Recruiting

• Conditions: Cystic Fibrosis; mucoviscidosis; 10083624

• Registration Number: NL-OMON51011
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Signed informed consent form (ICF )
- 18 years or older on the date of signed informed consent
- Diagnosis of cystic fibrosis confirmed by genotype analysis
- Current use of tezacaftor/ivacaftor in combination with ivacaftor
- If pancreas insufficient, current use of amylase/lipase/protease, creon
10.000

Exclusion Criteria

- Use of drugs that have a known influence on the CYP3A enzyme (inducers or
inhibitors)
- Pulmonary exacerbation with hospital admission in the month before study
participation (defined as need for intravenous antibiotics)
- Pregnancy or breast feeding

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pharmacokinetic paramaters (AUC, Tmax, Cmax and T*) of ivacaftor for<br /><br>pancreas sufficient patients and pancreas insufficient patients.<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Pharmacokinetic parameters for absorption and exposure of ivacaftor<br /><br>(AUC, Tmax, Cmax and T*) for pancreas insufficient patients with and without<br /><br>pancreas enzymes. The RAUC of ivacaftor (AUC with pancreas enzymes divided by<br /><br>AUC without pancreas enzymes) for pancreas insufficient patients.<br /><br>- Number of adverse and serious adverse events<br /><br><br /><br>Other study parameters:<br /><br>- Age<br /><br>- Gender<br /><br>- Height<br /><br>- Weight<br /><br>- Body mass index (BMI)<br /><br>- Fat free mass index (FFMI)<br /><br>- Use of co-medication </p><br>