Phase 1
Completed N=12
A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT03161405 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-906 — 9.532; 17.999 nanogram per milliliter (ng/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-906 |
9.532; 17.999 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 |
24.10; 30.73 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 |
24.41; 31.45 | — |
Eligibility Criteria
Inclusion Criteria
- 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 ( ) 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03161405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.