CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Formulation A GS-248 +1 moredrug
Likely dose
Formulation A GS-248 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04617509
NCT04617509Phase 1Completed
CompareCT.gov

An Open, One-sequence, Three-period Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Oral Single Dosing of Two Different Solid Formulations of GS-248

Gesynta Pharma AB·interventional·Posted Nov 5, 2020·Updated Aug 31, 2021

In Brief

A Phase 1 clinical trial evaluating Formulation A GS-248 and Formulation B GS-248 for Pharmacokinetic. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects. It will also collect information about pharmacokinetics (PK), safety and tolerability following a single dose of one of the two formulations of GS-248 in fed condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetic
CountriesSweden
CollaboratorsCTC Clinical Trial Consultants AB, Research Institutes of Sweden

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedNov 5, 2020
Enrollment StartMar 31, 2020
Primary CompletionMay 27, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.7 years ago

Interventions

Formulation A GS-248drug

Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.

Formulation B GS-248drug

Formulation B of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.