Pharmacokinetic evaluation of a pulmonary administered levodopa dry powder formulation in Parkinson*s disease.

Phase 2

Completed

• Conditions: Parkinsons disease; Parkinson; 10028037

• Registration Number: NL-OMON42667
• Lead Sponsor: Martini Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

- Signed informed consent.;- Diagnosed with Parkinson*s disease;- At least 18 years old. ;- Currently on stable Parkinson*s disease levodopa regimen.;- Require levodopa containing medication regimen with a maximum of 4 administrations a day.;- Able to perform spirometry.

Exclusion Criteria

- Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent.;- Pregnant or breast feeding.;- Active pulmonary disease. ;- Patients with known symptomatic orthostatic hypotension.;- The use of COMT inhibitors and/or MAO-B inhibitors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maximum levodopa concentration in plasma (Cmax).<br /><br>Time to maximum concentration (Tmax).<br /><br>Area under the concentration time (minutes) curve at 0-180 min (AUC0-180) after<br /><br>administration of the dose (related to the actual dose administered (weighed<br /><br>dose minus remained dose in inhaler after inhalation).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Absorption rate constant (Ka) of levodopa after pulmonary administration.<br /><br>Terminal elimination half life (T1/2el) of levodopa after pulmonary<br /><br>administration.<br /><br>Decrease of FEV1 in percentage measured by spirometry (at predose, 35 and 100<br /><br>minutes after administration.<br /><br>Number of participants with adverse events (both spontaneously reported and<br /><br>reported as a result of questioning by the researcher. </p><br>