Status:
COMPLETED
Local Tolerability and Pharmacokinetic Evaluation of Cyclops Dry Powder Hydroxychloroquine Inhalation in Healthy Volunteers
Lead Sponsor:
University Medical Center Groningen
Conditions:
Covid19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Rationale: This protocol describes a study on the local tolerability of dry powder hydroxychloroquine using the Cyclops in healthy volunteers. Objective: * Primary objective is to assess the local ...
Eligibility Criteria
Inclusion
- Healthy volunteer
- Age 18-65 years
- Obtained written informed consent
Exclusion
- Pregnancy or breastfeeding. Women in the fertility period and without using proper contraceptives will undergo a urine pregnancy test.
- Contra-indication to (hydroxy)chloroquine or quinine (allergic reaction, prolonged QTc-interval (\> 450 msec), long-QT syndrome (LQTS), retinopathy, epilepsia, myasthenia gravis, G6PD-deficiency).
- Concurrent use of ciclosporin, digoxin, ritonavir, tamoxifen or tranylcypromine.
- Concurrent use of high risk QTc prolongating drugs (amiodarone, erythromycin (daily dose \> 1000 mg) or sotalol)16.
- COVID-19 like symptoms, such as fever, couch, or sore throat; only by history taking.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04497519
Start Date
September 15 2020
End Date
November 1 2020
Last Update
November 10 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Groningen
Groningen, Netherlands