A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of CAD-1883 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of CAD-1883 in Healthy Subjects - CS0289 (CAD1883-101)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46676

Enrollment

128

Registered

2018-01-10

Start date

2018-01-30

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

CAD-1883 Matching placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
Safety (AEs, VS, Physical examination, Clinical laboratory assessments, ECG, telemetry) PK (Cmax, Tmax, AUC0-t, AUC0-inf)	—

Secondary

Measure	Time frame
PK (Cmax, Tmax, AUC0-t, AUC0-inf) Safety (AEs, VS, Physical examination, Clinical laboratory assessments, ECG, telemetry)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)