- Primary objective is to assess the local tolerability of dry powder hydroxychloroquine via the Cyclops* at different dosages.- Secondary objective is to investigate systemic pharmacokinetic parameters of dry powder hydroxychloroquine via the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The local tolerability of the inhalation of dry powder hydroxychloroquine
defined by a drop of forced expiratory volume in 1 second (FEV1) of >15% (lung
function measurement) and any other reported adverse events.
For the local tolerability of the inhalation of dry powder hydroxychloroquine
the drop of forced expiratory volume in 1 second (FEV1) of >15% (lung function
measurement) and any other reported adverse event are all considered critical
to decide on proceeding into a phase 2B (and/or a phase 3) trial.
Secondary outcome
The inspiratory parameters during the inhalation maneuver are critical to
explore predictors for drug exposure. The following parameters will be
calculated: dPmax (maximum pressure drop), Vi (inhaled volume), Ti (total
inhalation time), PIF (peak inspiratory flow rate), MIF (mean inspiratory flow
rate) and the FIR (average flow increase rate between 20% and 80% of PIF).
Actual inhaled dose (dose minus remainder in inhaler after inhalation) will be
calculated and blood samples will be drawn predose, at 0.5, 2 and 3.5 hrs after
inhalation.
Background summary
In this protocol, we will perform a study of the local tolerability of dry
powder hydroxychloroquine using the Cyclops* in healthy volunteers. A drop of
forced expiratory volume in 1 second (FEV1) of >15 % (lung function
measurement) and any other reported adverse events are all considered critical
to decide on proceeding into a phase 2B (and/or a phase 3) trial.
Study objective
- Primary objective is to assess the local tolerability of dry powder
hydroxychloroquine via the Cyclops* at different dosages.
- Secondary objective is to investigate systemic pharmacokinetic parameters of
dry powder hydroxychloroquine via the Cyclops at different dosages.
Study design
single center, ascending dose study
Intervention
not applicable
Study burden and risks
The participants included are healthy volunteers. They will receive three
different doses of hydroxychloroquine using the dry powder inhaler (DPI) with
(at least) one day in between doses. Before using the dry powder inhaler (DPI),
they will receive instructions and their inspiratory flow will be tested. To
investigate local tolerability, lung function tests will be performed and the
occurrence of adverse events will be scored. Furthermore, before each test dose
an indwelling cannula will be inserted and before and after each test dose in
total four blood samples will be collected.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteer
Age 18-65
Obtained written informed consent
Exclusion criteria
1. Pregnancy or breast feeding
2. Contra-indication to hydroxychloroquine or quinine (Allergic reaction,
prolonged QTc-interval (> 450 msec), long-QT syndrome (LQTS), retinopathy,
epilepsia, myasthenia gravis, G6PD-deficiency)
3. Concurrent use of amiodarone, ciclosporin, digoxin, erythromycin (daily dose
> 1000 mg), ritonavir, sotalol, tamoxifen or tranylcypromine
4. COVID-19 like symptoms, such as fever, couch, or sore throat; only by
history taking
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-001212-17-NL |
| CCMO | NL73484.042.20 |