Interventional, open-label, single- and sequential-ascending-dose study investigating the safety, tolerability and pharmacokinetic profile of Lu AF28996 in healthy young men.

Interventional, open-label, single- and sequential-ascending-dose study investigating the safety, tolerability and pharmacokinetic profile of Lu AF28996 in healthy young men. - CS0294 (17695A)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48715

Enrollment

Registered

2018-05-08

Start date

2018-06-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

movement disorders

Interventions

Domperidone 10 mg TID Pramipexol 0.125mg BID Lu AF28996

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. The subject has taken disallowed medication

Design outcomes

Primary

Measure	Time frame
PK	—

Secondary

Measure	Time frame
Safety and tolerability Compare PK of solution or capsule Evaluate food effect on PK on capsule	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)