Phase 1
Completed N=10
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
Healthy Participants
Source: ClinicalTrials.gov NCT03173170 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-954 — 2.642; 2.840 nanogram/milliliter (ng/mL)
Summary
The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-954 |
2.642; 2.840 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 |
28.59; 43.15 | — |
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) from 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.
- Had 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 (NCT03173170). 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.