An open-label, single-dose study to assess the relative bioavailability of 2 new formulations of UCB5857 versus the reference formulation, and to evaluate the mass balance recovery and the absolute bioavailability of UCB5857 using intravenous and oral microtracers in healthy subjects

Completed

• Conditions: rheumatoid arthritis; Sjögrens syndrome; 10003816

• Registration Number: NL-OMON41752
• Lead Sponsor: CB Celltech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

healthy subjects
18 - 55 yrs, inclusive
BMI : 18.0 - 30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the relative bioavailability of 2 new formulations of UCB5857<br /><br>administered orally versus the existing (reference) formulation<br /><br>administered orally.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the absolute bioavailability of UCB5857 when administered<br /><br>intravenously as a 14C-labeled MT together with an oral administration<br /><br>- To evaluate the mass balance recovery of UCB5857 when administered orally as<br /><br>a 14C-labeled MT together with an oral administration<br /><br>- To identify the metabolite profile (ie, quantitation and structure<br /><br>elucidation) of UCB5857 in plasma, urine, and feces<br /><br>- To evaluate the safety and tolerability of UCB5857</p><br>