TuberculosisPhase 1CL-009NCT01830439
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
A Phase 1 study testing PA-824 200mg and PA-824 50mg in people with Tuberculosis, run by Global Alliance for TB Drug Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- PA-824 200mg and PA-824 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 37Show fewer
- 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.
- Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes (including quinidine, tyramine, ketoconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan, etc.) or known to prolong the QT interval (including amiodarone, bepridil chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, quinolones, sotalol, sparfloxacin, thioridazine,) or barbiturates, opiates, or phenothiazines.
- Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine, etc.) within 30 days prior to dosing.
- Consumption of products containing grapefruit within 10 days prior to dosing.
- Any special dietary changes during the 30 days prior to dosing, as deemed by the Principal Investigator in consultation with the Sponsor Medical Monitor.
- Any strenuous exercise within 7 days of Check-in, as deemed by the Principal Investigator in consultation with the Sponsor Medical Monitor.
- Donation of whole blood or significant loss of blood within 56 days prior to dosing.
- Plasma donation within 7 days prior to dosing
- Participation in another interventional clinical trial within 30 days prior to dosing.
- Any serum creatinine or BUN measure beyond the upper limit of the normal range at Screening or Check-in. Individual values may be discussed with the Sponsor Medical Monitor.
- Hemoglobin < 12.0 g/dL at the screening and check-in visit.
- Positive Screening test for HCV, HBV, or HIV.
- Any other factor which suggests to the Principal Investigator that the subject should not participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
MDS Pharma Services (Celerion)
Lincoln, Nebraska, 68502
About this study
Official title: A Phase 1, Randomized, Balanced, Single-Dose, Two-Period, Two-Sequence, Crossover, Open-Label Study of the Effect of Food on the Bioavailability and Pharmacokinetics of PA-824 Tablets in Healthy Adult Subjects
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.
- Conditions
- Tuberculosis
- Being tested
- PA-824 200mg, PA-824 50mg
- Keywords
- tuberculosis, PK, PA-824, food effect, pretomanid, CL-009
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA-824 200mgDrug
Two single administrations of 200mg PA-824 each administered by four 50mg tablets, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days.
PA-824 50mgDrug
Two single administrations of 50mg PA-824 each administered by one 50mg tablet, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Fed PA-824 200mg | Experimental | 200 mg PA-824 (4 x 50 mg tablets) in Phase A was administered 30 minutes after the start of a high-calorie, high-fat breakfast provided after a minimum 10-hour overnight fast and was administered with 240 mL tap water. Receives: Drug: PA-824 200mg |
| Fasted PA-824 200 mg | Experimental | 200 mg PA-824 (4 x 50 mg tablets) in Phase A was administered 30 minutes after a minimum 10-hour overnight fast and was administered with 240 mL tap water. Receives: Drug: PA-824 200mg |
| Fed PA-824 50mg | Experimental | 50 mg PA-824 (1 x 50 mg tablets) in Phase B was administered 30 minutes after the start of a high-calorie, high-fat breakfast provided after a minimum 10-hour overnight fast and was administered with 240 mL tap water. Receives: Drug: PA-824 50mg |
| Fasted PA-824 50mg | Experimental | 50 mg PA-824 (1 x 50 mg tablets) in Phase B was administered after a minimum 10-hour overnight fast and was administered with 240 mL tap water. Receives: Drug: PA-824 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of the maximum drug concentration in hours [Tmax]
To compare the rate and extent of absorption as measured by Tmax of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. Tmax is obtained without interpolation.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Maximum observed drug concentration in ng/mL [Cmax]
To compare the rate and extent of absorption as measured by Cmax of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Area under the drug concentration-time curve in ng*hr/mL [AUC(0-t)]
To compare the rate and extent of absorption as measured by AUC(0-t) of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. AUC(0-t) is calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Area under the drug concentration-time curve from time zero to infinity in ng*hr/mL [AUC(0-inf)]
To compare the rate and extent of absorption as measured by AUC(0-inf) of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. AUC(0-inf) is calculated as AUC(0-t) + Ct/Kel.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Secondary outcomes (6)
Ratio of AUC(0-t) to AUC(0-inf) [AUC(0-t)/ AUC(0-inf)]
To compare AUC(0-t)/ AUC(0-inf) of a single oral dose of PA-824 tablets (200 mg in Phase A and 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Number of participants with adverse events
To compare the safety and tolerability as measured by the number of participants with adverse events after a single oral dose of PA-824 tablets (200 mg in Phase A and 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast.
Measured: through the study Day 13, and through Day 103 for SAE and ophthalmologic events
Elimination half-life in hours [t1/2]
To compare t1/2 of a single oral dose of PA-824 tablets (200 mg in Phase A and 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. T1/2 is calculated as ln (2)/Kel.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Terminal elimination rate constant in 1/hour [Kel]
To compare Kel of a single oral dose of PA-824 tablets (200 mg in Phase A and 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. Kel is calculated by linear regression of the terminal linear portion of the log concentration vs. time curve, using at least 3 data points
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Oral clearance in L/hour [Cl/F]
To compare Cl/F of a single oral dose of PA-824 tablets (200 mg in Phase A and 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. Cl/F is calculated as Dose/AUC(0-inf).
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Volume of distribution following oral administration in L [Vd/F]
To compare Vd/F of a single oral dose of PA-824 tablets (200 mg in Phase A and 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. Vd/F is calculated as (CL/F)/Kel.
Measured: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Alliance for TB Drug Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Rasmussen, MD, Principal investigator, MDS Pharma Services (Celerion)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830439
- Sponsor's protocol ID
- PA-824-CL-009
- Acronym
- CL-009
- Status last verified
- Sep 2019
- First submitted
- 12 Feb 2013
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Winter H, Ginsberg A, Egizi E, Erondu N, Whitney K, Pauli E, Everitt D. Effect of a high-calorie, high-fat meal on the bioavailability and pharmacokinetics of PA-824 in healthy adult subjects. Antimicrob Agents Chemother. 2013 Nov;57(11):5516-20. doi: 10.1128/AAC.00798-13. Epub 2013 Aug 26.
PubMed 23979737
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Balanced, Single-Dose, Two-Period, Two-Sequence, Crossover, Open-Label Study of the Effect of Food on the Bioavailability and Pharmacokinetics of PA-824 Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01830439
- Acronym / sponsor ID
- CL-009 / PA-824-CL-009
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, PK, PA-824, food effect, pretomanid, CL-009
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Global Alliance for TB Drug DevelopmentUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fed PA-824 200mg | Experimental | Drug: PA-824 200mg200 mg PA-824 (4 x 50 mg tablets) in Phase A was administered 30 minutes after the start of a high-calorie, high-fat breakfast provided after a minimum 10-hour overnight fast and was administered with 240 mL tap water. |
| Fasted PA-824 200 mg | Experimental | Drug: PA-824 200mg200 mg PA-824 (4 x 50 mg tablets) in Phase A was administered 30 minutes after a minimum 10-hour overnight fast and was administered with 240 mL tap water. |
| Fed PA-824 50mg | Experimental | Drug: PA-824 50mg50 mg PA-824 (1 x 50 mg tablets) in Phase B was administered 30 minutes after the start of a high-calorie, high-fat breakfast provided after a minimum 10-hour overnight fast and was administered with 240 mL tap water. |
| Fasted PA-824 50mg | Experimental | Drug: PA-824 50mg50 mg PA-824 (1 x 50 mg tablets) in Phase B was administered after a minimum 10-hour overnight fast and was administered with 240 mL tap water. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (37 listed)
- 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:
- History of prolonged QT interval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA-824 200mgTwo single administrations of 200mg PA-824 each administered by four 50mg tablets, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days. | Drug | Fasted PA-824 200 mg, Fed PA-824 200mg |
| PA-824 50mgTwo single administrations of 50mg PA-824 each administered by one 50mg tablet, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days. | Drug | Fasted PA-824 50mg, Fed PA-824 50mg |
Primary outcome
Time of the maximum drug concentration in hours [Tmax]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
To compare the rate and extent of absorption as measured by Tmax of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. Tmax is obtained without interpolation.
Maximum observed drug concentration in ng/mL [Cmax]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
To compare the rate and extent of absorption as measured by Cmax of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast.
Area under the drug concentration-time curve in ng*hr/mL [AUC(0-t)]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
To compare the rate and extent of absorption as measured by AUC(0-t) of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. AUC(0-t) is calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration.
Area under the drug concentration-time curve from time zero to infinity in ng*hr/mL [AUC(0-inf)]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
To compare the rate and extent of absorption as measured by AUC(0-inf) of a single oral dose of PA-824 tablets (200 mg in Phase A and either 50 mg or 400 mg in Phase B) in healthy adult male and female subjects when PA-824 is administered after a high-calorie, high-fat meal and when it is administered after a minimum 10-hour fast. AUC(0-inf) is calculated as AUC(0-t) + Ct/Kel.
6 secondary outcomes
Ratio of AUC(0-t) to AUC(0-inf) [AUC(0-t)/ AUC(0-inf)]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Number of participants with adverse events
Time frame: through the study Day 13, and through Day 103 for SAE and ophthalmologic events
Elimination half-life in hours [t1/2]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Terminal elimination rate constant in 1/hour [Kel]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Oral clearance in L/hour [Cl/F]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Volume of distribution following oral administration in L [Vd/F]
Time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 23979737Winter H, Ginsberg A, Egizi E, Erondu N, Whitney K, Pauli E, Everitt D. Effect of a high-calorie, high-fat meal on the bioavailability and pharmacokinetics of PA-824 in healthy adult subjects. Antimicrob Agents Chemother. 2013 Nov;57(11):5516-20. doi: 10.1128/AAC.00798-13. Epub 2013 Aug 26.
- Global Alliance for TB Drug Development websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Rasmussen, MD principal investigator
MDS Pharma Services (Celerion)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PA-824 200mg and PA-824 50mg in people with Tuberculosis, run by Global Alliance for TB Drug Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of the maximum drug concentration in hours [Tmax] (time frame: mean through 36 hours after each dose with measurements at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, and 36 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01830439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.