A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Iā¦ (NCT01568411) | Clinical Trial Compass
CompletedPhase 1
A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211
United States20 participantsStarted 2012-04
Plain-language summary
This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4) and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg tablet of TD- 1211 administered orally to fasted subjects.
Who can participate
Age range18 Years ā 50 Years
SexALL
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Inclusion criteria
ā. Willing and able to give written, signed informed consent
ā. Male and female subjects 18 to 50 years of age (inclusive)
ā. Body mass index 19 to 30 kg/m2 (inclusive), and weigh at least 55 kg
ā. No clinically important abnormal physical findings at the screening or Period 1, Day -1 examinations
ā. Normal blood pressure (BP) and heart rate (HR). These will be measured after resting seated or supine for approximately 5 minutes. Normal BP is defined as 90 to 140 mm Hg systolic and 50 to 85 mm Hg diastolic. Normal HR is defined as 45 to 90 beats per minute
ā. Negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody within the last 3 months (documentation must be provided for confirmation)
ā. No clinically relevant abnormalities in the results of Screening or Period 1, Day -1 laboratory evaluations
ā. Ability to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and direction of the clinic staff
Exclusion criteria
ā. Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, or neurological disease
ā. Any condition possibly affecting drug absorption (e.g., previous surgery on the GI tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\])
ā. Any other condition that, in the opinion of the Investigator, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
ā. Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
ā. Unwilling to abstain from ingestion of caffeine or xanthine containing products (e.g., tea, coffee, chocolate, cola, etc.) beginning 48 hours before the dosing of study medication (Day 1) until the final PK sample in each period
ā. History of hypersensitivity to drugs with a clinically significant reaction
ā. Any history of alcoholism or drug abuse (in the past year) or positive screen for drugs of abuse or alcohol at Screening or Day -1 of each period.
ā. Unwilling to abstain from alcohol beginning 48 hours prior to study dose administration (Day 1) until the collection of the final PK sample in each period.