The purpose of the study is to investigate the maximum effect of ADASUVE on repolarization of the heart. This is the process where the cells of the heart muscle recharge again after contraction. If this process is strongly slowed down, (potentially…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Agitatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics: Plasma concentrations, pharmacokinetic parameters
Safety: Adverse events, vital signs, ECG-parameters, laboratory parameters,
physical examination
Secondary outcome
n/a
Background summary
Loxapine is a registered drug that is used for the treatment of agitation.
Agitation is an emotional state of excitement or restlessness that is a severe
complication of many chronic mental illnesses, including schizophrenia and
dementia.
In this study loxapine will be administered via a registered oral inhalator
(ADASUVE).
In addition, moxifloxacin, a registered drug that is used for the treatment of
a number of bacterial infections, will be administered.
Study objective
The purpose of the study is to investigate the maximum effect of ADASUVE on
repolarization of the heart. This is the process where the cells of the heart
muscle recharge again after contraction. If this process is strongly slowed
down, (potentially risky) abnormalities of the heart rhythm may occur.
In addition, it will be investigated how quickly and to what extent ADASUVE is
absorbed and eliminated from the body (this is called pharmacokinetics).
Study design
This is a single center, randomized, double-blind, double dummy, 2 dose, 3
period, active and placebo controlled QT/QTc and pharmacokinetic study of
ADASUVE in healthy volunteers.
Intervention
All subjects will be exposed to 3 different treatments.
A Inhalator: 10 mg ADASUVE, twice daily + Oral: Placebo, once daily
B Inhalator: Placebo, twice daily + Oral: Placebo, once daily
C Inhalator: Placebo, twice daily + Oral: 400 mg Moxifloxacin, once daily
In period 1, 2 and 3 the subjects will be randomly assigned to treatment A, B
and C.
Study burden and risks
- possible side-effects as decribed under E9
- venipunctures and blood draws via cannula
- screening and follow-up visit
- admission to the clinic
- study activities: physical examination, ECG, blood pressure and heart rate
measurements, vital signs and holter
2091 Stierlin Court
94043 Mountain View, California
NL
2091 Stierlin Court
94043 Mountain View, California
NL
Listed location countries
Age
Inclusion criteria
- healthy male or female (females with child bearing potential have to use an effective method of contraception)
- between 18 and 65 years of age, inclusive
- BMI between 18 and 32 kg/m2, inclusive
- no smoking during at least 30 days prior to the screening
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 3 months from the start of the study.
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 | EUCTR2013-001317-32-NL |
| CCMO | NL44498.056.13 |