TP-3654 Food Effect Study

Part of paid clinical trials in Secaucus, New Jersey.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT07492355
Phase
PHASE1
Status
Completed

Conditions

  • Myelofibroses

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • TP-3654 — DRUG
    capsule, oral administered

Study Details

This clinical trial will determine the bioavailability and effect of food on TP-3654 in healthy adult participants.

Key Dates

Start date
Mar 4, 2024
Status verified
Mar 2026
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

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

Arms

  • Experimental: Part A
    Randomized, single-dose, 3-period, 3-way cross-over study to assess the relative bioavailability of TP-3654 capsule formulation (1:5 ratio of API:excipient) vs capsule formulations using a 1:3 and 1:2 of API:excipient ratio.
  • Experimental: Part B
    Randomized, single-dose, 3-period, 3-way cross-over study to evaluate the effect of food on the PK of the Sponsor's selected TP-3654 capsule formulation (1:3 or 1:2).

Primary Outcome Measure

The Cmax for relative bioavailability of TP-3654 in Part A [ Time Frame: 13 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Frontage ClinicalSecaucusNew Jersey07094-

Find similar trials in Secaucus, NJ

By research site
Frontage Clinical· Secaucus, NJ

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