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Completed

NCT Number: NCT03555617

Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study

This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.

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Key information

Conditions

Inflammatory Bowel Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Additional inclusion criteria apply

Exclusion criteria

  • Planning to conceive a child during the study or within 2 months after the last dose of study drug
  • Is positive for hepatitis A, B or C, and/or HIV
  • 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 is currently participating in another trial of an investigational drug (or medical device)
  • Additional exclusion criteria apply

Treatment and study plan

TD-1473

Drug

oral capsule/tablet, QD

Itraconazole

Drug

oral solution, QD

Primary outcomes

  1. Maximum observed concentration (Cmax) in Plasma

    Time frame: Up to 8 days post-dose

  2. Time to maximum observed concentration (tmax) in Plasma

    Time frame: Up to 8 days post-dose

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

    Time frame: Up to 8 days post-dose

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

    Time frame: Up to 8 days post-dose

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

    Time frame: Up to 8 days post-dose

  6. Apparent clearance (Cl/F) in Plasma

    Time frame: Up to 8 days post-dose

  7. Apparent volume of distribution (Vz/F) in Plasma

    Time frame: Up to 8 days post-dose

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2018
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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