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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2017-11-08

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

TD-3504

Intervention Type DRUG

TD-3504

15N2-tofacitinib

Intervention Type DRUG

15N2-tofacitinib

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.

Group Type EXPERIMENTAL

TD-3504

Intervention Type DRUG

TD-3504

15N2-tofacitinib

Intervention Type DRUG

15N2-tofacitinib

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.

Group Type EXPERIMENTAL

TD-3504

Intervention Type DRUG

TD-3504

15N2-tofacitinib

Intervention Type DRUG

15N2-tofacitinib

Placebo

6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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TD-3504

Intervention Type DRUG

15N2-tofacitinib

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female between 18 to 55 years old
* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
* Body Mass Index (BMI) 18 to 32 kg/m2
* Willing and able to give informed consent

* Subject has a history of UC
* Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days

Exclusion Criteria

* Is positive for hepatitis A, B or C, HIV or tuberculosis
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device)

* Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes