A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4 inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.
Key facts
- Study ID
- NCT03161405
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 12
- Starts
- 2017-06-05
- Expected to finish
- 2017-07-10
- Last updated by the study team
- 2019-01-11
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.
- Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m\^2) and a body weight greater than (>) 50 kilogram (kg) at the Screening Visit.
- Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug/invasive procedure.
You may not qualify if…
- Has a positive alcohol or drug screen.
- Has had a major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 8 weeks of the first dose of study drug.
- Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Has a substance abuse disorder.
Where it is running
- Takeda Investigational Site — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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