NCT03417830

Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging

An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	GSK2315698 (CPHPC)	GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.
DRUG	GSK2398852 (unlabeled anti-SAP mAb)	Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.
DRUG	89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)	89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.

Timeline

• Start date: 2018-04-06
• Primary completion: 2018-07-20
• Completion: 2018-07-20
• First posted: 2018-01-31
• Last updated: 2019-08-29
• Results posted: 2019-08-29

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated drug study