Hearing LossPhase 1NCT02259595
Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC
A Phase 1 study testing HPN-07 and NAC in people with Hearing Loss and Sensorineural Hearing Loss, run by Otologic Pharmaceutics, Inc. at 1 site in United States.
Trial summary
This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to approximately 32 healthy male and female subjects between 18 and 55 years of age. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural Hearing Loss, Noise-Induced Hearing Loss
- What is being tested?
- HPN-07 and NAC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Feb 2015
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, 18-55 years of age (inclusive), at the time of enrollment.
- Healthy as judged by a responsible physician with no clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead electrocardiogram (ECG). A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures (as defined as the research site's standard operating procedures).
- Male subjects who are surgically sterile OR agree to abstain from sexual intercourse with a female partner OR agree to use a condom and spermicide during sexual intercourse with a female partner who meets the following criteria: 1) uses another form of contraception, such as an intrauterine device (IUD), occlusive cap (diaphragm or cervical/vault cap) with spermicide, oral contraceptives, injectable progesterone, subdermal implants, female condom, contraceptive patch, or contraceptive vaginal ring; and/or 2) has had a tubal ligation or hysterectomy. These criteria must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication. Men must also abstain from sperm donation from the time of the first dose of study medication until 14 days after the last dose of study medication.
- Female subjects of childbearing potential must be practicing abstinence or are using, and willing to continue using, a medically acceptable form of birth control for at least 1 month prior to Screening (at least 3 months for hormonal contraceptives) and for at least 2 months after the last study drug administration. Medically acceptable forms of contraception include abstinence, hormonal contraceptives (oral, patch or vaginal ring), intrauterine device, progestin implant or injection, bilateral tubal ligation, or double-barrier methods (i.e., male condom in addition to a diaphragm or a contraceptive sponge).
- Female subjects of non-childbearing potential, defined as: having undergone successful surgical sterilization (hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy, as determined by subject medical history) or post-menopausal. Postmenopausal is defined as being amenorrheic for at least 1 year without another cause and a follicle-stimulating hormone (FSH) level ~50 mlU/ml.
- Female subjects must have a negative pregnancy test at screening and Day -1 (admission).
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- Minimum body weight of 50.0 kg and body mass index (BMI) between 18.0 kg/m2 and 33.0 kg/m2 (inclusive).
- Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc:, for 6 months prior to the administration of the study medication) and has negative findings on a breath carbon monoxide (CO) test.
- Willing and able to comply with study instructions and commit to all follow-up visits, and willing and able to abide by all study requirements and restrictions.
- Ability to understand, agree to, and sign the study informed consent form (ICF) prior to initiation of any protocol related procedures.
Who cannot join
- Self-reported substance or alcohol dependence or abuse (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and/or subjects who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- History of serious adverse reactions or hypersensitivity to any drug; or known allergy to any of the test product(s), or any components in the test product(s); or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the Investigator's Brochure; or severe allergic reaction (including anaphylaxis) to any food, or bee stings or previous status asthmaticus.
- History of renal stones or taking cardiac nitrates.
- Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial or may interfere with the distribution, metabolism, or excretion of drugs.
- Abnormal physical findings of clinical significance, at screening or on Day -1, which would interfere with the objectives of the study.
- History or presence of orthostatic hypotension (~20 mmHg drop in systolic blood pressure, or ~10 mmHg drop in diastolic blood pressure, or subject experiences lightheadedness or dizziness) at screening or on Day-1.
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- Clinically significant abnormal laboratory values (as determined by the Investigator) at the screening evaluation.
- Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
- 12-lead ECG obtained at screening with PR >240 msec, QRS >110 msec, and QTc >440 msec for males and >450 msec for females, bradycardia (<50 bpm), or clinically significant minor ST wave changes on the screening ECG or any other changes on the screening ECG that would interfere with measurement of the QT interval.
- Major surgical interventions within 6 months before the study.
- Has a positive pre-study hepatitis B surface antigen; positive hepatitis C virus (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive human immunodeficiency virus (HIV) antibody result.
- Use of a prohibited medication or supplement, as specified in Section 9.6.
- Has a history of regular alcohol consumption averaging >14 drinks/week for men and >9 drinks/week for women (1 drink (10 g alcohol] = 100 ml of wine or 280 ml of standard strength beer or 30 ml of 80 proof distilled spirits) within 6 months of the screening visit.
- Loss of 500 ml, or more, of blood during the 3-month period before the drug administration, e.g., blood donor.
- Symptoms of a significant somatic or mental illness in the 4-week period preceding drug administration, as per investigator discretion.
- Exclude subjects with a positive breath alcohol test or urine drug screen at screening. Suspected false positive results may be repeated at the discretion of the Investigator.
- Concurrent participation in another drug or device research study or within 30 days of participation in another drug or device research study.
- Considered by the Investigator to be an unsuitable candidate for this study.
- Women who are breastfeeding, pregnant, or intend to become pregnant during the course of the study.
- An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Research Associates
Raleigh, North Carolina, 27612
About this study
Official title: Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC in Single Doses in Male and Female Subjects
This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to approximately 32 healthy male and female subjects between 18 and 55 years of age.
Subjects will receive single oral doses of the study drug. The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC).
Read the detailed description
This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to healthy male and female subjects between 18 and 55 years of age.
Approximately 32 subjects will be enrolled in a panel of 4 cohorts with approximately 8 subjects per cohort. There will be approximately 3 sequential ascending dosing levels of HPN-07, with each cohort administered 1 dose of HPN-07 ranging from 500 mg to 1,500 mg and the fourth cohort administered the highest tolerated dose of HPN-07 plus 1,200 mg NAC.
The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC). Pharmacokinetics (PK) analysis of HPN-07 will enable a preliminary determination of the relationship between dose and the time course of the drug concentration in the body. Blood samples will be collected at regular intervals over the predicted time of HPN-07 systemic exposure.
- Being tested
- HPN-07, NAC, Placebo
- Keywords
- Hearing Loss, Sensorineural Hearing Loss, Noise-Induced Hearing Loss, Antioxidant, NAC, N-acetylcysteine, HPN-07
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPN-07Drug
Also called disufenton sodium, Disodium 4-[(tert-butylimino)methyl]benzene-1,3-disulfonate N-oxide
500-1,500 mg oral capsules administered in a single dose
NACDrug
Also called N-acetylcysteine, acetylcysteine, N-acetyl-L-cysteine
1,200mg NAC administered via oral capsule in single dose
PlaceboDrug
placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| HPN-07 500 mg / Placebo | Experimental | Single dose of 500mg HPN-07 plus placebo in oral capsules. Receives: Drug: HPN-07; Drug: Placebo |
| HPN-07 1000 mg / Placebo | Experimental | Single dose of 1,000mg HPN-07 plus placebo in oral capsules Receives: Drug: HPN-07; Drug: Placebo |
| HPN-07 1500 mg / Placebo | Experimental | Single dose of 1,500mg HPN-07 plus placebo in oral capsules Receives: Drug: HPN-07; Drug: Placebo |
| HPN-07 MTD plus NAC 1200mg | Experimental | Single dose of maximum tolerated dose of HPN-07 plus 1,200 mg NAC in oral capsules. Dose selection will be determined from safety data of previous cohorts by Data Assessment Committee (DAC). Receives: Drug: HPN-07; Drug: NAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single doses of HPN-07, alone and in co-administration with NAC: Adverse events
The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus NAC. The following safety parameters will be evaluated for adverse events as determined by: 12-lead ECG, clinical laboratory tests, urinalysis, and vital signs.
Measured: 48 hours
Secondary outcomes (6)
Area under the curve (AUC) of single doses of HPN-07, alone and in co-administration with NAC
Measured: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Maximum observed plasma concentration (Cmax) of single doses of HPN-07, alone and in co-administration with NAC
Measured: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Half life (t1/2) of single doses of HPN-07, alone and in co-administration with NAC
Measured: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Volume of distribution (Vz) of single doses of HPN-07, alone and in co-administration with NAC
Measured: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Mean transit time (MTT) of single doses of HPN-07, alone and in co-administration with NAC
Measured: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Total clearance (CL) of single doses of HPN-07, alone and in co-administration with NAC
Measured: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otologic Pharmaceutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Treva Tyson, MD, Principal investigator, Wake Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259595
- Sponsor's protocol ID
- HPN-07-PK-101
- Status last verified
- Apr 2015
- First submitted
- 2 Sep 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC in Single Doses in Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02259595
- Acronym / sponsor ID
- HPN-07-PK-101
- Keywords
- Hearing Loss, Sensorineural Hearing Loss, Noise-Induced Hearing Loss, Antioxidant, NAC, N-acetylcysteine, HPN-07
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Otologic Pharmaceutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Oct 2014 (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 study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to approximately 32 healthy male and female subjects between 18 and 55 years of age.
Subjects will receive single oral doses of the study drug. The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC).
Detailed description
This study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to determine the safety, tolerability, and PK profile of oral administration of HPN-07 in single doses to healthy male and female subjects between 18 and 55 years of age.
Approximately 32 subjects will be enrolled in a panel of 4 cohorts with approximately 8 subjects per cohort. There will be approximately 3 sequential ascending dosing levels of HPN-07, with each cohort administered 1 dose of HPN-07 ranging from 500 mg to 1,500 mg and the fourth cohort administered the highest tolerated dose of HPN-07 plus 1,200 mg NAC.
The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus N-acetylcysteine (NAC). Pharmacokinetics (PK) analysis of HPN-07 will enable a preliminary determination of the relationship between dose and the time course of the drug concentration in the body. Blood samples will be collected at regular intervals over the predicted time of HPN-07 systemic exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HPN-07 500 mg / Placebo | Experimental | Drug: HPN-07, Drug: PlaceboSingle dose of 500mg HPN-07 plus placebo in oral capsules. |
| HPN-07 1000 mg / Placebo | Experimental | Drug: HPN-07, Drug: PlaceboSingle dose of 1,000mg HPN-07 plus placebo in oral capsules |
| HPN-07 1500 mg / Placebo | Experimental | Drug: HPN-07, Drug: PlaceboSingle dose of 1,500mg HPN-07 plus placebo in oral capsules |
| HPN-07 MTD plus NAC 1200mg | Experimental | Drug: HPN-07, Drug: NACSingle dose of maximum tolerated dose of HPN-07 plus 1,200 mg NAC in oral capsules. Dose selection will be determined from safety data of previous cohorts by Data Assessment Committee (DAC). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects, 18-55 years of age (inclusive), at the time of enrollment.
- Healthy as judged by a responsible physician with no clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead electrocardiogram (ECG). A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures (as defined as the research site's standard operating procedures).
- Male subjects who are surgically sterile OR agree to abstain from sexual intercourse with a female partner OR agree to use a condom and spermicide during sexual intercourse with a female partner who meets the following criteria: 1) uses another form of contraception, such as an intrauterine device (IUD), occlusive cap (diaphragm or cervical/vault cap) with spermicide, oral contraceptives, injectable progesterone, subdermal implants, female condom, contraceptive patch, or contraceptive vaginal ring; and/or 2) has had a tubal ligation or hysterectomy. These criteria must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication. Men must also abstain from sperm donation from the time of the first dose of study medication until 14 days after the last dose of study medication.
- Female subjects of childbearing potential must be practicing abstinence or are using, and willing to continue using, a medically acceptable form of birth control for at least 1 month prior to Screening (at least 3 months for hormonal contraceptives) and for at least 2 months after the last study drug administration. Medically acceptable forms of contraception include abstinence, hormonal contraceptives (oral, patch or vaginal ring), intrauterine device, progestin implant or injection, bilateral tubal ligation, or double-barrier methods (i.e., male condom in addition to a diaphragm or a contraceptive sponge).
- Female subjects of non-childbearing potential, defined as: having undergone successful surgical sterilization (hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy, as determined by subject medical history) or post-menopausal. Postmenopausal is defined as being amenorrheic for at least 1 year without another cause and a follicle-stimulating hormone (FSH) level ~50 mlU/ml.
Key exclusion criteria (20 listed)
- Self-reported substance or alcohol dependence or abuse (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and/or subjects who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- History of serious adverse reactions or hypersensitivity to any drug; or known allergy to any of the test product(s), or any components in the test product(s); or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the Investigator's Brochure; or severe allergic reaction (including anaphylaxis) to any food, or bee stings or previous status asthmaticus.
- History of renal stones or taking cardiac nitrates.
- Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial or may interfere with the distribution, metabolism, or excretion of drugs.
- Abnormal physical findings of clinical significance, at screening or on Day -1, which would interfere with the objectives of the study.
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 |
|---|---|---|
| HPN-07Also: disufenton sodium, Disodium 4-[(tert-butylimino)methyl]benzene-1,3-disulfonate N-oxide500-1,500 mg oral capsules administered in a single dose | Drug | HPN-07 1000 mg / Placebo, HPN-07 1500 mg / Placebo, HPN-07 500 mg / Placebo, HPN-07 MTD plus NAC 1200mg |
| NACAlso: N-acetylcysteine, acetylcysteine, N-acetyl-L-cysteine1,200mg NAC administered via oral capsule in single dose | Drug | HPN-07 MTD plus NAC 1200mg |
| Placeboplacebo oral capsule | Drug | HPN-07 1000 mg / Placebo, HPN-07 1500 mg / Placebo, HPN-07 500 mg / Placebo |
Primary outcome
Safety and tolerability of single doses of HPN-07, alone and in co-administration with NAC: Adverse events
Time frame: 48 hours
The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and HPN-07 plus NAC. The following safety parameters will be evaluated for adverse events as determined by: 12-lead ECG, clinical laboratory tests, urinalysis, and vital signs.
6 secondary outcomes
Area under the curve (AUC) of single doses of HPN-07, alone and in co-administration with NAC
Time frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Maximum observed plasma concentration (Cmax) of single doses of HPN-07, alone and in co-administration with NAC
Time frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Half life (t1/2) of single doses of HPN-07, alone and in co-administration with NAC
Time frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Volume of distribution (Vz) of single doses of HPN-07, alone and in co-administration with NAC
Time frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Mean transit time (MTT) of single doses of HPN-07, alone and in co-administration with NAC
Time frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
Total clearance (CL) of single doses of HPN-07, alone and in co-administration with NAC
Time frame: pre-dose, 5, 15, and 30 min, and 1, 2, 4, 6, 8, 12, 24, and 48h post dosing
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 1 May 2015.
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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.
Treva Tyson, MD principal investigator
Wake Research Associates
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 HPN-07 and NAC in people with Hearing Loss and Sensorineural Hearing Loss, run by Otologic Pharmaceutics, Inc. 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 10 inclusion and 20 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 1 May 2015. 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?
Safety and tolerability of single doses of HPN-07, alone and in co-administration with NAC: Adverse events (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2015.