Viewing Study NCT04654143



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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