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A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248

NCT04617509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-08-31

Study results available
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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.

Conditions

  • Pharmacokinetic

Interventions

DRUG

Formulation A GS-248

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

DRUG

Formulation B GS-248

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

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Research Institutes of Sweden

    collaborator OTHER

  • Gesynta Pharma AB

    lead INDUSTRY

Principal Investigators

  • Helena Litorp, MD, PhD · CTC Clinical Trial Consultants AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2020-05-27
Completion
2020-05-27

Countries

  • Sweden

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 NCT04617509 on ClinicalTrials.gov