A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07465731
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Centanafadine SR — DRUG
    Oral tablets.
  • Centanafadine QD XR — DRUG
    Oral capsules.

Study Details

The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.

Key Dates

Start date
Oct 27, 2022
Status verified
Mar 2026
Primary completion
Mar 26, 2023
Completion
Mar 26, 2023

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR
    Participants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4.
  • Experimental: Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR
    Participants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4.
  • Experimental: Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR
    Participants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4.
  • Experimental: Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR
    Participants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4.
  • Experimental: Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed
    Participants receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fed state on Day 4.
  • Experimental: Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted
    Participants receive CTN 328.8 mg, QD XR, capsule, orally in fed state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 4.

Primary Outcome Measure

Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine [ Time Frame: Up to Day 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON, plc.,LenexaKansas66219-

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