TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

NCT03408470 | Completed Phase 1 FDA Drug

• 1 other identifier: 0152
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of \[14C\]-TD-1473. Subjects in cohort 2 will receive a single oral dose of \[14C\]-TD-1473 only.

Conditions

Intestinal Disorders; Bowel Diseases, Inflammatory

Keywords

Absolute Bioavailability; ADME; Healthy Normal Males

Outcome Measures

Primary Outcomes (8)

• Maximum observed concentration (Cmax) in Plasma

  Up to 15 days

• Time to maximum observed concentration (tmax) in Plasma

  Up to 15 days

• Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma

  Up to 15 days

• Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma

  Up to 15 days

• Apparent terminal elimination half-life (t1/2) in Plasma

  Up to 15 days

• Apparent clearance (Cl/F) in Plasma

  Up to 15 days

• Apparent volume of distribution (Vz/F) in Plasma

  Up to 15 days

• Absolute bioavailability (%F) in Plasma

  Up to 15 days

Secondary Outcomes (5)

• Amount excreted in urine (Aeu) over the sampling interval in Urine

  Up to 15 days

• Renal clearance (CLr) in Urine

  Up to 15 days

• The percent excreted in urine (%Feu) in Urine

  Up to 15 days

• Amount excreted in feces (Aef) over the sampling interval in Feces

  Up to 15 days

• The percent excreted in feces (%Fef)

  Up to 15 days

Other Outcomes (3)

• Metabolites in Plasma

  Up to 15 days

• Metabolites in Urine

  Up to 15 days

• Metabolites in Feces

  Up to 15 days

Study Arms (2)

TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus

EXPERIMENTAL

Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473

Drug: TD-1473 oral capsule; Drug: [14C]-TD-1473 IV bolus

[14C]-TD-1473 Oral Capsule

EXPERIMENTAL

Cohort 2 - One oral dose

Drug: [14C]-TD-1473 Oral Capsule

Interventions

TD-1473 oral capsule DRUG

(Intervention description included in arm description)

TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus

[14C]-TD-1473 IV bolus DRUG

(Intervention description included in arm description)

TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus

[14C]-TD-1473 Oral Capsule DRUG

(Intervention description included in arm description)

[14C]-TD-1473 Oral Capsule

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Males only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
• Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
• Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1

You may not qualify if:

• Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\])
• Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
• Subject regularly works with ionizing radiation or radioactive material
• Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
• Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Intestinal Diseases; Inflammatory Bowel Diseases

Interventions

izencitinib

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 24, 2018
• Study Start: January 31, 2018
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)