An open label positron emission tomography (PET) imaging study using 89-Zirconium labelled GSK3128349 to investigate the biodistribution and clearance of an albumin binding domain antibody (AlbudAb) GSK3128349 following single dose intravenous administration in healthy male subjects.

An open label positron emission tomography (PET) imaging study using 89-Zirconium labelled GSK3128349 to investigate the biodistribution and clearance of an albumin binding domain antibody (AlbudAb) GSK3128349 following single dose intravenous administration in healthy male subjects. - AlbudAb PET study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42953

Enrollment

Registered

2016-07-14

Start date

2016-08-23

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

niet van toepassing not applicable

Interventions

Not applicable.

89-Zirconium

GSK3128349

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 50 - 65 years of age, inclusive BMI 19.0 - 31.0 kilograms/meter2 non smokers or less than 5 cigarettes per day

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
Evaluate biodistribution of 89Zr-GSK3128349 in regions of interest following IV administration to support future AlbudAb products and the development of a PBPK model.	—

Secondary

Measure	Time frame
Measure PK of 89Zr-GSK3128349 by whole blood, plasma and urine radiolabel detection to support future AlbudAb products and the development of a PBPK model. Measure PK of GSK8128349 by mass spectroscopy (MS) to support the development of a PBPK model. Measure dosimetry of 89Zr-GSK3128349 from PET scans and blood radioactivity. Assess the safety and tolerability of 89Zr-GSK3128349. Investigate the presence and levels of anti-GSK3128349 antibodies, including pre and post-dose.	—

Measure

Time frame

Measure PK of 89Zr-GSK3128349 by whole blood, plasma and urine radiolabel detection to support future AlbudAb products and the development of a PBPK model. Measure PK of GSK8128349 by mass spectroscopy (MS) to support the development of a PBPK model. Measure dosimetry of 89Zr-GSK3128349 from PET scans and blood radioactivity. Assess the safety and tolerability of 89Zr-GSK3128349. Investigate the presence and levels of anti-GSK3128349 antibodies, including pre and post-dose.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)