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Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers

NCT04654143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-18

No results posted yet for this study

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

BVL-GSK098 capsule, placebo

Oral QD

Sponsors & Collaborators

  • BioVersys AG

    lead INDUSTRY

Principal Investigators

  • Rosa M Antonijoan, MD · Institut de Recerca de l'HSCSP. IIB Sant Pau.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2022-05-30
Completion
2023-01-16

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654143 on ClinicalTrials.gov