A study to assess the safety, tolerability and pharmacokinetic properties of CEP-37248, a drug for the treatment of autoimmune inflammatory diseases, in healthy men.

A study to assess the safety, tolerability and pharmacokinetic properties of CEP-37248, a drug for the treatment of autoimmune inflammatory diseases, in healthy men. - CEP-37248 SAD Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40424

Enrollment

Registered

2013-07-31

Start date

2013-08-12

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Autoimmune disease

Interventions

CEP-37248

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy males 18 -45 years BMI of 18.0 to 30.0 kg/m2 Weight at least 50 kg

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Safety, Tollerability	—

Secondary

Measure	Time frame
PK	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)