Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)

Completed · Phase 1

Conditions studied: Tuberculosis

In brief

This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and extent of absorption of two doses of PA-824 (50mg or 400 mg and 200mg) are the same after a high-calorie, high-fat meal as compared with after a minimum 10-hour fast. For each of the two dose levels 16 subjects with approximately 8 men and 8 women, will be enrolled for a total of 32 subjects.

Key facts

Study ID

NCT01830439

Run by

Global Alliance for TB Drug Development

People needed

32

Starts

2009-09-01

Expected to finish

2010-01-01

Last updated by the study team

2019-09-06

Who can join

Age: 19 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have the ability to understand the requirements of the study, have provided written informed consent (as evidenced by signature on an informed consent document approved by an IRB), and agree to abide by the study restrictions.
• Be healthy non-tobacco/nicotine using (6-month minimum) adult subjects, 19 to 50 years of age, inclusive.
• Be medically healthy subjects with clinically insignificant Screening results (among laboratory profiles, medical histories, ECGs, or physical exam), as deemed by the Principal Investigator.
• Have a body mass index of 18 to 29.
• Have negative urine test results for alcohol and drugs of abuse such as amphetamines, cannabinoids, and cocaine metabolites at both Screening and Check-in.
• Agree to follow the requirements set forth in the protocol regarding pregnancy controls and donation of sperm, blood, or blood components.

You may not qualify if…

• Any clinically significant (as deemed by the Principal Investigator) history, acute illness (resolved within 4 weeks of screening), or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including eating disorders), endocrine, metabolic, immunologic, dermatologic, neurologic, psychological, or psychiatric disease.
• History of peptic ulcer disease, gastritis, esophagitis, or gastroesophageal reflux disease.
• History of any cardiac abnormality (as deemed by the Principal Investigator).
• Any clinically significant ECG abnormality at Screening (as deemed by the Principal Investigator and the Sponsor's Medical Monitor). Note: the following can be considered not clinically significant without consulting Sponsor's Medical Monitor:
• Sinus bradycardia with heart rate ≥50 beats per minute (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects)
• Mild first degree A-V block (P-R interval <0.23 sec)
• Right or left axis deviation
• Incomplete right bundle branch block
• Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic subjects
• History of prolonged QT interval.
• Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease or CHF or terminal cancer)
• Resting pulse rate < 40 or > 100 bpm at Screening.
• At Screening blood pressure greater than 140/90 mm Hg or below 95/65 mm Hg (supine, after a minimum 5-minute supine rest)
• At either Screening or the pre-dose read before the first dose, a QTcB (Bazett's correction) >450ms for men and women, calculated from the average of triplicate reads collected at one sitting.
• At either Screening or the pre-dose read before the first dose, a QTcF (Fridericia's correction) >450ms for men and women, calculated from the average of triplicate reads collected at one sitting.
• History of hypokalemia or hypomagnesemia.
• History or presence of alcoholism or drug abuse within the past 2 years (as deemed by the Principal Investigator).
• Use of alcohol within 72 hours prior to dosing.
• Significant history of drug and/or food allergies (as deemed by the Principal Investigator).
• For women, subject is pregnant (positive test for serum HCG at Screening or Check-in), breastfeeding or planning to conceive a child within 1 week of cessation of treatment.
• For males, planning to father a child within 12 weeks of cessation of treatment.
• History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination.
• Any contraindication to the use of nitroimidazoles or prior treatment with PA-824 or OPC-67683.
• Use of any systemic or topical prescription medication within 14 days prior to dosing or during the study, except hormonal contraceptives in women
• Use of any systemic or over-the-counter medication including vitamins, herbal preparations, antacids, cough and cold remedies, etc., within 7 days prior to dosing or during the study.

Where it is running

• MDS Pharma Services (Celerion) — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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