A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants
About this clinical trial
The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of TAK-828 in healthy participants.
At a glance
What medical conditions were being studied?
What was the clinical trial testing?
Placebo, TAK-828
How many participants were enrolled?
24
When was the clinical trial conducted?
Jun 2016 - Aug 2016
Key requirements
Sexes
All
Age
18 to 55 Years
Healthy volunteers?
Yes
Inclusion:
For Parts 1 and 2, participant eligibility is determined according to the following
criteria prior to entry into the study:
1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable
representative, signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedures including
requesting that a participant fast for any laboratory evaluations.
3. The participant is a healthy male, or a healthy female not of child-bearing
potential. Females not of childbearing potential are defined as those who have been
surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or
who are postmenopausal (example, defined as at least 1 year since last regular
menses, with a follicle-stimulating hormone [FSH] level of greater than (>) 40
international units per liter [IU/L] or at least 5 years since last regular menses
confirmed before any study drug is administered).
4. For Part 1: the participant is a non-Japanese adult, aged 18 to 55 years (inclusive)
at the time of informed consent and first dose of study drug.
5. For Part 1: the participant weighs at least 50 kilogram (kg) and has a body mass
index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) (inclusive) at Screening.
6. For Part 2: the participant is of Japanese descent (born to Japanese parents and
grandparents), aged 20 to 55 years (inclusive) at the time of informed consent and
first dose of study drug.
7. For Part 2: the participant weighs at least 45 kg and has a BMI of 18.5 to 25 kg/m^2
(inclusive) at Screening.
Exclusion Criteria
For Parts 1 and 2, any participant who meets any of the following criteria will not
qualify for entry into the study:
1. The participant received any investigational compound within 30 days or 5 half-lives
(whichever is longer) before the first dose of study drug.
2. The participant used prescription or nonprescription drugs and dietary supplements
within 7 days or 5 half-lives (whichever is longer) before Check-in (Day -1). Herbal
supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior
to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less
than or equal to (<=) 1 gram/day. Limited use of nonprescription medications that
are not believed to affect participant safety or the overall results of the study
may be permitted on a case-by-case basis following approval by the sponsor.
3. The participant is an immediate family member or study-site employee or is in a
dependent relationship with a study-site employee who is involved in the conduct of
this study (example, spouse, parent, child, sibling) or may consent under duress.
4. The participant has a history or presence of any disease or condition (or there is
any finding upon review of the participant's medical history, physical examination,
or clinical laboratory tests giving reasonable suspicion of a disease) that could
interfere with study participation or safety, contraindicate taking TAK-828 or a
similar drug in the same class, or potentially confound the study results (example,
history or presence of clinically significant neurologic, cardiovascular, pulmonary,
hepatic, hematologic, renal, immunologic, metabolic, musculoskeletal,
gastrointestinal, endocrine, or psychiatric disease). It is the responsibility of
the investigator to assess the clinical significance; however, consultation with the
Takeda medical monitor may be warranted.
5. The participant has a known hypersensitivity to any component of the formulation of
TAK-828.
6. The participant has an active infection at Screening.
7. The participant has a positive urine drug result for drugs of abuse (defined as any
illicit drug use) at Screening or Check-in (Day -1).
8. The participant has a history of drug abuse (defined as any illicit drug use) or a
history of alcohol abuse within 1 year, or the participant drinks 7 or more
drinks/week for females or 14 or more drinks/week for males (1 drink=5 ounces [150
milliliter {mL}] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard
liquor) within 6 months before the Screening visit or is unwilling to abstain from
alcohol and drugs throughout the study.
9. The participant is taking or took any excluded medication, supplements, or food
products during the time periods listed in the Prohibited Medications, Foods, and
Products table
10. If male, the participant intends to donate sperm during the course of this study or
for 14 weeks after the last dose of study drug.
11. The participant has any condition possibly affecting drug absorption (example,
gastrectomy).
12. The participant has a history of cancer, except basal cell carcinoma that has been
in remission for at least 5 years before Screening.
13. The participant has a positive test result for hepatitis B surface antigen (HBsAg)
or hepatitis C virus (HCV) antibody at Screening or has a known history of human
immunodeficiency virus (HIV) infection.
14. The participant used nicotine-containing products (including, but not limited to,
cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within
28 days prior to Check-in (Day -1) or cotinine test is positive at Screening or
Check-in (Day -1).
15. The participant has poor peripheral venous access.
16. The participant donated or lost 450 mL or more of his or her blood volume (including
plasmapheresis) or had a transfusion of any blood product within 30 days prior to
Day 1.
17. The participant has a Screening or Check-in (Day -1) abnormal (clinically
significant) ECG. Entry of any participant with an abnormal (not clinically
significant) ECG must be approved, and documented by signature of the principal
investigator or medically qualified subinvestigator.
18. The participant has abnormal Screening or Day -1 laboratory values that suggest a
clinically significant underlying disease or the participant has the following
laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate
aminotransferase (AST) > 3 times the upper limit of normal (ULN).
19. The participant has a creatine kinase isoenzyme MB (CK-MB) or cardiac troponin above
the ULN at Screening or Day -1.
20. If female, the participant is of childbearing potential (example, premenopausal, not
sterilized).
Study results
View study results on registries
For researchers
About
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