IBD, Inflammatory Bowel Diseases
Conditions
Keywords
Healthy Japanese Subjects, Healthy Caucasian Subjects, Ethnobridging
Brief summary
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.
Interventions
DRUGTD-1473 - Dose A
oral capsule/tablet, QD
DRUGTD-1473 - Dose B
oral capsule/tablet, QD
DRUGTD-1473 - Dose C
oral capsule/tablet, QD
DRUGPlacebo
oral capsule/tablet, QD
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve (AUC0 t) | Day 1 & Day 14 |
| Area under the concentration-time curve (AUC0 24) | Day 1 & Day 14 |
| Area under the concentration-time curve (AUCtau) | Day 1 & Day 14 |
| Maximum observed concentration (Cmax) | Day 1 & Day 14 |
| Maximum observed concentration at steady state (Cmax_ss) | Day 1 & Day 14 |
Countries
United States
Outcome results
None listed