An Open-label, Randomized, Three-period, Crossover Study to compare the Pharmacokinetics of GB1211 upon dosing a capsule under fasting condition and a tablet under fasting and fed conditions in healthy volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502200-67-00

Acronym

GB1211-CPH-005

Enrollment

Registered

2022-12-20

Start date

2022-12-27

Completion date

2023-04-10

Last updated

2023-04-04

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

Conditions

Non-small Cell Lung Cancer, Advanced liver Fibrosis and Cirrhosis

Brief summary

Plasma PK parameters including but not limited to: AUC0-last, AUC0-inf, Cmax, Tmax, CL/F, Vz/F and urine PK parameters including but not limited to Ae and Fe.

Detailed description

Safety and tolerability parameters including: physical examination, weight, AEs, clinical laboratory values, vital signs and 12-lead ECGs.

Interventions

DRUG5-Bromopyridin-3-yl 3-deoxy-3-[4-(3

DRUG4

DRUG5-trifluorophenyl)-1H-1

DRUG2

DRUG3-triazol-1-yl]-1-thio-α-D-galactopyranoside

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Plasma PK parameters including but not limited to: AUC0-last, AUC0-inf, Cmax, Tmax, CL/F, Vz/F and urine PK parameters including but not limited to Ae and Fe.	—

Secondary

Measure	Time frame
Safety and tolerability parameters including: physical examination, weight, AEs, clinical laboratory values, vital signs and 12-lead ECGs.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026