Lu AF28996 is an orally administered investigational compound of a potent, long-acting dopamine agonist, Lu AA40326, currently under development by H. Lundbeck A/S for the treatment of Parkinson*s disease (PD). Primary Objective:to investigate the…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PK
Secondary outcome
Safety and tolerability
Compare PK of solution or capsule
Evaluate food effect on PK on capsule
Background summary
Lu AF28996 is an orally administered investigational compound of a potent,
long-acting dopamine agonist, Lu AA40326, currently under development by H.
Lundbeck A/S for the treatment of Parkinson*s disease (PD).
Study objective
Lu AF28996 is an orally administered investigational compound of a potent,
long-acting dopamine agonist, Lu AA40326, currently under development by H.
Lundbeck A/S for the treatment of Parkinson*s disease (PD).
Primary Objective:
to investigate the pharmacokinetic characteristics of Lu AF28996 after single
and sequential ascending oral doses administered as a solution to healthy young
men
Secondary objectives:
to investigate the safety and tolerability of Lu AF28996 after single and
sequential ascending oral doses to healthy young men
to compare the pharmacokinetic properties of Lu AF28996 following a single oral
dose administered as a solution or a capsule in fasting state to healthy young
men
to evaluate the effect of food on the pharmacokinetic properties of Lu AF28996
following a single oral dose administered as a capsule to healthy young men
Study design
This is an interventional, open-label, single- and sequential-ascending-dose
study investigating the safety, tolerability and pharmacokinetic profile of Lu
AF28996 in healthy young men.
Part A will consist of Cohorts 1 to 6 with the possibility of including 4
additional Cohorts. Eighteen healthy men that will all receive Lu AF28996 is
planned for enrolment, with 3 subjects per cohort (cohort 1-6). A maximum of 4
additional cohorts, with 4 subjects in cohort 7 and 3 subjects in cohort 8-10
of young healthy men will be permitted before the protocol is amended, thereby
allowing investigation of a maximum of 31 subjects.
In Cohort 1, the subjects will receive a single oral dose of Lu AF28996.
Following safety, tolerability and preliminary pharmacokinetic (PK) results
including mean t* of Lu AF28996, subjects in Cohorts 2-6 will receive two
sequential ascending oral doses of Lu AF28996 with a washout in between.
Following each cohort, a dosing conference will be held where tolerability,
safety and preliminary PK results from the previous cohorts will be reviewed
before deciding on the next planned doses. Depending on the cohort findings,
the dosing plan may be altered to include a decrease in dose/doses, or a
repetition of dose/doses with relevant exposure.
Part B is an open-label three-period crossover study in healthy young men to
compare the PK of an oral capsule formulation with that of an oral solution
formulation and to evaluate food effect following oral capsule administration
of Lu AF28996.
In Part B, 8 subjects will each receive a total of 3 doses of Lu AF28996
either in the fast or fed state (following a high-fat breakfast), according to
4 possible sequences. Each Treatment Period will be separated by a washout
period of *3 days.
Subjects will be administered prophylactic antiemetic treatment in terms of
oral domperidone 10 mg TID the days before dosing and on dosing days.
The total duration of Part B per subject from the Safety Baseline to the end of
Follow-up Visit will be approximately 25 days.
Intervention
Domperidone 10 mg TID
Pramipexol 0.125mg BID
Lu AF28996
Study burden and risks
In Part A, the dosage levels of the study drug are based on a previous clinical
trial conducted by the sponsor. The dose for Part B is the same for all
treatments and will be selected based on the safety, tolerability and PK
results of Part A.
The risk to health at the chosen dose is limited, but the patients may
experience any of the side effects in the ICF or symptoms that have not been
reported before.
Volunteers health is closely monitored during the study to minimize these
risks.
If the volunteers experience side effects, the investigator will treat them
where necessary. If new information is available on the safety of the study
medication, the volunteers are informed as soon as possible. The blood
collection procedure is not dangerous.
Petrus Campersingel 123
Groningen 9713 AG
NL
Petrus Campersingel 123
Groningen 9713 AG
NL
Listed location countries
Age
Inclusion criteria
Healthy, young, non-smoking men aged *18 and *45 years and with a body mass index (BMI) *18.5kg/m2 and *30kg/m2 at the Screening Visit, who has demonstrated tolerability to oral pramipexol. ;Further inclusion criteria can be found in the protocol on page 45/46.
Exclusion criteria
1. The subject has taken disallowed medication <1 week prior to the first dose of IMP or 5 half-lives prior to the Screening Visit for any medication taken.
2. The subject has significant alcohol consumption.
3. The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP.;Further exclusion criteria can be found in the protocol on page 46/47
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 | EUCTR2017-003600-46-NL |
| CCMO | NL65850.056.18 |