The purpose of this study is to evaluate the oral bioavailability of two new tablet
formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed
conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the
pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4
Formulation C tablet.
The drug being tested in this study is called TAK-385. In this study, two new formulations
of TAK-385 are being evaluated under fasted and fed conditions, relative to a previous
formulation of TAK-385, to assess its bioavailability and how it is processed by the body.
This study will look at lab results of people who take TAK-385.
The study will enroll approximately 54 patients. Participants will be randomly assigned (by
chance, like flipping a coin) to one of the two treatment groups (Arms). Participants in Arm
1 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted
conditions, TAK-385 T4 Formulation B 120 mg tablet under fasted conditions, and TAK-385 T4
Formulation B 120 mg tablet under fed conditions. Participants in Arm 2 will receive TAK-385
T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4
Formulation C 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation C 120 mg
tablet under fed conditions. Participants in each arm will be randomized to receive study
drug in one of 6 treatment sequences. Study medication will be administered as a single dose
on Days 1, 11 and 21. There will be a 10-day washout period between each dose.
This single-centre trial will be conducted in the United States. The overall time to
participate in this study is 51 days. Participants will make 10 visits to the clinic,
including three 4-day periods of confinement to the clinic, and will be contacted by
telephone 30 days after last dose of study drug for a follow-up assessment.
1. Age 18 to 55 years, inclusive, at the time of consent.
2. Healthy adult male, as determined by a physician evaluation that includes:
- Medical history (ie, no clinically significant medical conditions requiring
ongoing drug therapy).
- Physical examination.
- Vital signs.
- Laboratory evaluation (hematology, biochemistry, and urinalysis).
- No acute illness within 30 days before screening that required prescription or
over-the-counter (OTC) medicines.
3. Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m^2 inclusive, at
4. Nonsmoker for at least 2 years and does not use nicotine-containing products
(including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or
nicotine patch or gum).
5. Male participants, even if surgically sterilized (ie, status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study
treatment period and through 4 months after the last dose of study drug, or
- Agree to practice true abstinence, when this is in line with the preferred and
usual lifestyle of the participant. (Periodic abstinence [eg, calendar,
ovulation, symptothermal, postovulation methods for the female partner] and
withdrawal are not acceptable methods of contraception.)
6. Voluntary written consent must be given before performance of any study-related
procedure not part of standard medical care, with the understanding that consent may
be withdrawn by the participant at any time without prejudice to future medical care.
7. Suitable venous access for the study-required blood sampling.
8. Abstains from behavior that increases susceptibility to contract blood-borne
pathogens (eg, obtaining a tattoo or participating in unsafe needle use for any
purpose) during the 28 days before study entry.
9. In the opinion of the investigator, the participant or legal guardian is capable of
understanding and complying with protocol requirements.
1. Has any serious medical or psychiatric illness that could, in the investigator's
opinion, potentially interfere with the completion of treatment according to this
2. Has received any investigational compound within 30 days (or 5 half- lives of the
compound, if longer) before check-in (Day -1).
3. Has received TAK-385 in a previous clinical study.
4. Has current or recent (within 6 months) history of gastrointestinal disease that
would be expected to influence the absorption of drugs (ie, history of malabsorption,
esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent heartburn, or
any surgical intervention).
5. Is lactose intolerant.
6. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per
day) within 1 year before screening or is unwilling to agree to abstain from alcohol
and drugs throughout the study.
7. Has a positive test result for hepatitis B surface antigen (HBsAG) or hepatitis C
virus (HCV) antibody at Screening.
8. Has a positive urine drug result for drugs of abuse or alcohol at Screening or
check-in (Day -1).
9. Has taken any prescription medicine or herbal preparations (eg, St. John's wort) or
received any immunizations within 30 days before check-in (Day -1).
10. Has taken any OTC medications or vitamin supplements within 14 days before check-in
(Day -1). Excluded from this list is occasional use of acetaminophen (paracetamol) ≤
1 g/day or other medication approved by the sponsor on a case-by-case basis.
11. Is unwilling to agree to abstain from caffeine and food products from 72 hours before
check-in (Day -1) to completion of the study.
12. Has a clinically significant electrocardiogram (ECG) abnormality at Screening or
check-in (Day -1) or a QTc interval (by the Fridericia correction) of 450 msec or
greater. The participant has a history of cardiac disease including, but not limited
to, congenital long-QT syndrome, torsades de pointes or torsades de pointes risk
factors (eg, cardiac insufficiency, hypokalemia, family history of long-QT syndrome,
current use of Class IA [eg, quinidine or procainamide] or Class III [eg, amiodarone
or sotalol] antiarrhythmic medications or other medications with known effects on QT
13. Has abnormal laboratory values suggesting a clinically significant disease at
Screening or check-in (Day -1) or has abnormalities in the following laboratory
parameters: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
value >1.5 times the upper limit of normal.
14. Has engaged in heavy exercise (marathon running, weight lifting, etc) within 72 hours
before check-in (Day -1) or is unwilling to agree to abstain from heavy exercise
throughout the study.
15. Has known allergy to TAK-385 or its excipients.
16. Participants who, for any reason, are deemed by the investigator to be inappropriate
for this study, including participants who are unable to communicate or to cooperate
with the investigator.
17. Any participant who is an immediate family member, investigational site employee, or
in a dependent relationship with an investigational site employee who is involved in
conduct of this study (eg, spouse, parent, child, sibling) or may consent under