Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT02396147
Run by: Takeda
People needed: 54
Starts: 2015-03-01
Expected to finish: 2015-06-01
Last updated by the study team: 2016-07-25

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Age 18 to 55 years, inclusive, at the time of consent.
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.
Electrocardiogram (ECG).
Laboratory evaluation (hematology, biochemistry, and urinalysis).
No acute illness within 30 days before screening that required prescription or over-the-counter (OTC) medicines.
Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive, at Screening.
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).
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.)
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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Suitable venous access for the study-required blood sampling.
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.
In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements.

You may not qualify if…

Has any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Has received any investigational compound within 30 days (or 5 half- lives of the compound, if longer) before check-in (Day -1).
Has received TAK-385 in a previous clinical study.
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).
Is lactose intolerant.
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.
Has a positive test result for hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody at Screening.
Has a positive urine drug result for drugs of abuse or alcohol at Screening or check-in (Day -1).
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).
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.
Is unwilling to agree to abstain from caffeine and food products from 72 hours before check-in (Day -1) to completion of the study.
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 interval).
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.
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.
Has known allergy to TAK-385 or its excipients.
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.
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 duress.

Where it is running

Study site — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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