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Multiple Dose Ethnobridging PK Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03750565
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases IBD Drug: TD-1473 - Dose A Drug: TD-1473 - Dose B Drug: TD-1473 - Dose C Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : February 13, 2019

Arm Intervention/treatment
Experimental: Cohort 1
Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
Drug: TD-1473 - Dose A
oral capsule/tablet, QD

Drug: Placebo
oral capsule/tablet, QD

Experimental: Cohort 2
Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
Drug: TD-1473 - Dose B
oral capsule/tablet, QD

Drug: Placebo
oral capsule/tablet, QD

Experimental: Cohort 3
Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
Drug: TD-1473 - Dose B
oral capsule/tablet, QD

Drug: Placebo
oral capsule/tablet, QD

Experimental: Cohort 4
Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
Drug: TD-1473 - Dose C
oral capsule/tablet, QD

Drug: Placebo
oral capsule/tablet, QD




Primary Outcome Measures :
  1. Area under the concentration-time curve (AUC0 t) [ Time Frame: Day 1 & Day 14 ]
  2. Area under the concentration-time curve (AUC0 24) [ Time Frame: Day 1 & Day 14 ]
  3. Area under the concentration-time curve (AUCtau) [ Time Frame: Day 1 & Day 14 ]
  4. Maximum observed concentration (Cmax) [ Time Frame: Day 1 & Day 14 ]
  5. Maximum observed concentration at steady state (Cmax_ss) [ Time Frame: Day 1 & Day 14 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For All subjects:

  • Male or female between 18 to 55 years old
  • Female subjects must have documentation of a negative serum pregnancy test,
  • Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method
  • Male subjects must be vasectomized with documented medical assessment of the surgical success, or use acceptable contraception
  • All male subjects must agree to refrain from sperm donation during the study and for at least 7 days after the last dose of study drug.
  • Body Mass Index (BMI) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less than 90 kg
  • Willing and able to give informed consent
  • Additional inclusion criteria apply

For Japanese subjects only:

  • Subject must have been born in Japan, with 2 Japanese biological parents and 4 Japanese grandparents as confirmed by interview.
  • Subject has lived no longer than 10 years outside of Japan.
  • Subject had no significant change in lifestyle, including diet, since leaving Japan.

For Caucasian subjects only:

  • Subject has 2 Caucasian biological parents and 4 Caucasian grandparents as confirmed by interview.
  • Subject has lived no longer than 10 years outside of Europe and/or North America.

Exclusion Criteria:

For all subjects:

  • Subject is a female who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study or within 7 days after the last dose of study drug.
  • Subject is a male who is planning to father a child during the study or within 7 days 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750565


Locations
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United States, California
Theravance Biopharma Investigational Site
Cypress, California, United States, 90630
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03750565     History of Changes
Other Study ID Numbers: 0176
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theravance Biopharma:
Healthy Japanese Subjects
Healthy Caucasian Subjects
Ethnobridging

Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases