TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

Conditions

• Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• TD-3504 — DRUG
  TD-3504
• 15N2-tofacitinib — DRUG
  15N2-tofacitinib
• Placebo — DRUG
  Placebo

Study Details

This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.

Key Dates

Start date

May 4, 2017

Status verified

Jan 2021

Primary completion

Nov 8, 2017

Completion

Nov 8, 2017

Study Design

Enrollment

32 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TD-3504 Low-Dose
  6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
• Experimental: TD-3504 Mid-Dose
  6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
• Experimental: TD-3504 High-Dose
  6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
• Placebo Comparator: Placebo
  6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.

Primary Outcome Measure

Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events [ Time Frame: Day 1 through Day 8 ]

Locations (1)

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