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

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 - UCB5857 mass balance and absolute bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41752

Enrollment

Registered

2015-02-24

Start date

2015-03-04

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

rheumatoid arthritis Sjögrens syndrome

Interventions

The study will consist of 3 treatment periods during which you will receive UCB5857 in different formulations. In Period 1 participants will be divided into Period 1a (6 participants) or Period 1b

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To determine the relative bioavailability of 2 new formulations of UCB5857 administered orally versus the existing (reference) formulation administered orally.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)