Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04654143
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2020-11-15
Brief Title:
Clinical Trial to Investigate the Safety Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers
Sponsor:
BioVersys AG
Organization:
BioVersys AG
Study Overview
Official Title:
A Phase I Double-blind Randomized Placebo-controlled Study to Investigate the Safety Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I single-center double-blind randomized placebo-controlled study to investigate the safety tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers
Detailed Description:
This is an exploratory first-in-human FIH double-blind randomized placebo-controlled single and multiple ascending oral dose study in healthy volunteersThe study will be divided into two parts that will be conducted sequentially Part A is a SAD study to determine the safety tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers In addition the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098 Part B is a MAD study to determine the safety tolerability and PK of BVL-GSK098 following multiple daily oral doses in healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None