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A phase 1, first human exposure, single dose, double-blind, randomized, placebo controlled trial to assess the safety, tolerability, pharmacokinetics and pharmaco-dynamics after oral administration of Org 48775-0 in healthy male volunteers in fasted and fed state, in female healthy volunteers, and in rheumatoid arthritis patients with active disease while on methotrexate treatment.

A phase 1, first human exposure, single dose, double-blind, randomized, placebo controlled trial to assess the safety, tolerability, pharmacokinetics and pharmaco-dynamics after oral administration of Org 48775-0 in healthy male volunteers in fasted and fed state, in female healthy volunteers, and in rheumatoid arthritis patients with active disease while on methotrexate treatment. - Phase 1 Org 48775-0

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32271
Enrollment
50
Registered
2007-12-03
Start date
2007-12-20
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Rheumatoid arthritis

Interventions

Healthy male volunteers: Single oral dose(s) of study drug in an escalating dose design with randomised placebo Healthy post-menopausal females: Single oral dose of study drug Patients: Single oral

Sponsors

Organon Nederland BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male volunteers: healthy Female volunteers: healthy and post-menopausal Patients: active disease and treatment with MTX

Exclusion criteria

Exclusion criteria: Volunteers: clinically significant abnormalities (females: possible fertile) Patients: clinically significant abnormalities (females: possible fertile) and recent treatment with anti-TNF therapy

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics of drug Pharmacodynamics of drug (ao measurement of inhibition in TNF-release after ex-vivo LPS stimulation) Routine clinical annd lab parameters

Secondary

MeasureTime frame
Transcriptomics / Proteomics

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)