Staccato Prochlorperazine Thorough QT/QTc

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiotoxicity

In brief

To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.

Key facts

Study ID

NCT00543062

Run by

Alexza Pharmaceuticals, Inc.

People needed

48

Starts

2007-10-01

Expected to finish

2007-12-01

Last updated by the study team

2019-03-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects between the ages of 18 to 65 years, inclusive.
• Body mass index (BMI) ≥21 and ≤30.
• Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 3-day period and 3 consecutive 2-day periods.
• Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
• Subjects who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
• Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.

You may not qualify if…

• Subjects who regularly consume large amounts of xanthine-containing substances must be excluded.
• Subjects who have taken prescription or nonprescription medication within 5 days of Treatment Period 1 must be excluded.
• Subjects who have had an acute illness within the last 5 days of Treatment Period 1 must be excluded.
• Subjects who have smoked tobacco within the last year must be excluded.
• Subjects who have a history of HIV positivity must be excluded.
• Subjects who have a history of allergy or intolerance to prochlorperazine or phenothiazines must be excluded.
• Subjects who have a history of contraindication to anticholinergics must be excluded.
• Subjects who have a history of pheochromocytoma, seizure disorder, Parkinson's disease, or Restless Leg Syndrome must be excluded.
• Subjects who have an ECG abnormality must be excluded.
• Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
• Subjects who have a history of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded.
• Subjects who have a history of asthma or chronic obstructive lung disease must be excluded.
• Subjects who have hypotension (systolic ≤90 mmHg, diastolic ≤50 mmHg), or hypertension (systolic ≥140 mmHg, diastolic blood pressure ≥90 mmHg) must be excluded.
• Subjects who test positive for alcohol or have a positive urine drug screen must be excluded.
• Female subjects who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
• Subjects who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
• Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.
• Subjects who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion present undue risk to the subject or may confound the interpretation of study results must be excluded.

Where it is running

• Covance Clinical Research Unit Inc. — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.