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

NCT03103412 | Completed Phase 1 FDA Drug

• 1 other identifier: 0146
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events

  To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.

  Day 1 through Day 8

Secondary Outcomes (9)

• Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values

  Day 1 through Day 8

• Systemic area under the curve of TD-3504

  Day 1 through Day 4

• Systemic Cmax of TD-3504

  Day 1

• Systemic area under the curve of tofacitinib

  Day 1 through Day 4

• Systemic Cmax of tofacitinib

  Day 1

Study Arms (4)

TD-3504 Low-Dose

EXPERIMENTAL

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.

Drug: TD-3504; Drug: 15N2-tofacitinib

TD-3504 Mid-Dose

EXPERIMENTAL

6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.

Drug: TD-3504; Drug: 15N2-tofacitinib

TD-3504 High-Dose

EXPERIMENTAL

6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.

Drug: TD-3504; Drug: 15N2-tofacitinib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TD-3504 DRUG

TD-3504

TD-3504 High-Dose; TD-3504 Low-Dose; TD-3504 Mid-Dose

15N2-tofacitinib DRUG

15N2-tofacitinib

TD-3504 High-Dose; TD-3504 Low-Dose; TD-3504 Mid-Dose

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 6, 2017
• Study Start: May 4, 2017
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)