NCT04617509

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Gesynta Pharma AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is divided in two parts. Part I will evaluate PK, safety and tolerability of a single oral dose of two different formulations of GS-248 in fasting conditions. Part II will evaluate PK, safety and tolerability of one of the two different formulations of GS-248 in fed conditions. In Part I, a single oral dose of GS-248 in two different solid formulations will be administered to 14 healthy subjects. All subjects will first receive Formulation A and then Formulation B. A wash-out period of at least 4 days will be applied between the IMP administrations. Both doses contain 120 mg GS 248. For Part I, subjects will come to the clinic for single dose administration of Formulation A or Formulation B, respectively, and PK and safety assessments. Safety assessments include AE reporting, physical examination, ECG, vital signs, body temperature, and blood sampling for analysis of safety laboratory parameters. After evaluation of the PK profiles of Formulation A and B in Part I of the study, one formulation will be selected to be given following intake of a standardised breakfast in Part II of the study. Subjects will return to the clinic for a second dose of the selected formulation, yet now in fed conditions. The assessments during fed conditions will be the same as during fasting conditions except that the subjects will consume a high-fat high-calorie breakfast 30 minutes prior to IMP administration.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-31
• Primary completion: 2020-05-27
• Completion: 2020-05-27
• First posted: 2020-11-05
• Last updated: 2021-08-31
• Results posted: 2021-08-31

Locations

1 site across 1 country: Sweden