A Comparative Study of Selatogrel (ACT-246475) Formulations in Healthy Subjects

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Viatris Innovation GmbH
Study ID
NCT04557280
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • Selatogrel — COMBINATION_PRODUCT
    A single subcutaneous injection of 16 mg.
  • Selatogrel — DRUG
    A single subcutaneous injection of 16 mg.

Study Details

The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations.

Key Dates

Start date
Nov 6, 2020
Status verified
Nov 2022
Primary completion
Dec 19, 2020
Completion
Dec 19, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment A: liquid formulation via auto-injector
    Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an auto-injector forming an integral ready-to-use single-dose drug delivery system.
  • Experimental: Treatment B: liquid formulation via syringe
    Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe.
  • Experimental: Treatment C: lyophilizate-based formulation via syringe
    Selatogrel will be administered as a reconstituted lyophilizate-based formulation for injection.

Primary Outcome Measure

Area under the plasma concentration-time curve (AUC0-t) of selatogrel [ Time Frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Kansas, IncOverland ParkKansas66212-

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Altasciences Clinical Kansas, Inc· Overland Park, KS

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