Multiple Dose Ethnobridging PK Study in Healthy Subjects

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: IBD; Inflammatory Bowel Diseases

Treatments: Drug: TD-1473 - Dose C; Drug: TD-1473 - Dose A; Drug: Placebo; Drug: TD-1473 - Dose B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03750565

0176

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: TD-1473 - Dose A

Drug: Placebo

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: TD-1473 - Dose B

Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: TD-1473 - Dose B

Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: TD-1473 - Dose C

Drug: Placebo