Opioid-Related DisordersPhase 1NCT03137030
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
A Phase 1 study testing GRT7014 - Abuse Deterrend Tablet and Norco 5Mg-325Mg Tablet in people with Opioid-Related Disorders and Pain, Acute, run by Grünenthal GmbH at 1 site in United States.
Trial summary
This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of different amounts of tablets of a new and a marketed tablet formulation in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Pain, Acute, Pain, Postoperative
- What is being tested?
- GRT7014 - Abuse Deterrend Tablet and Norco 5Mg-325Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2017to Jan 2018
- 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
- Subjects have given written informed consent to participate.
- Body mass index between 20 kg/m2 and 30 kg/m2 inclusive, with a minimal body weight of 60 kg.
- Subjects must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant deviations from reference ranges as determined by 12-lead electrocardiogram (ECG), vital signs (blood pressure, pulse rate, respiratory rate), body temperature, oxygen saturation, and safety laboratory parameters (hematology, clinical chemistry, clotting, and urinalysis).
- From the first administration of IMP until at least 4 weeks (for women)/90 days (for men) after the Final Examination, subjects must agree to use highly effective contraception with a low failure rate defined as <1% per year.
- For female subjects of childbearing potential:
- Combined (estrogen and progestogen containing) hormonal contraception.
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- Progestogen-only hormonal contraception associated with inhibition of ovulation.
- An intra-uterine device (hormone-free).
- An intra-uterine hormone releasing system (IUS).
- Bilateral tubal occlusion.
- Women of non-childbearing potential may be included if surgically sterile (i.e., after hysterectomy or bilateral oophorectomy) or post-menopausal for at least 12 months (i.e., spontaneous amenorrhea at least 1 year prior to screening with confirmed follicle-stimulating hormone level >40 IU/L).
- For male subjects:
- Male subjects have to use barrier contraception (condom) during sexual intercourse with women of childbearing potential from the first application of IMP until at least 90 days after the Final Examination. The male subject has to be willing to ensure that the female sexual partner uses at least 1 additional method of contraception with a low failure rate defined as <1% per year until at least 90 days after the Final Examination.
Who cannot join
- Withdrawal of informed consent.
- Received forbidden medication or an investigational medical device since the Enrollment Visit.
- Any relevant deterioration in the health of the subject since the Enrollment Visit possibly impacting participation in the trial at the discretion of the investigator, including: adverse events; vital signs (relevant out-of-reference blood pressure or pulse rate if technical failure can be excluded and result is confirmed by at least 1 additional measurement); physical examination, 12-lead ECG (relevant QTc prolongation if result is confirmed by 1 additional ECG measurement and manual re-evaluation by the investigator); other safety parameters.
- Blood loss of 100 mL or more since enrollment in this trial (excluding blood taken for this trial).
- Resting pulse rate <50 beats per minute or >90 beats per minute.
- Resting systolic blood pressure <90 mmHg or >140 mmHg. Resting diastolic blood pressure >90 mmHg.
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- Prolongation of corrected QT interval (according to Fridericia's formula; QTcF), i.e., QTcF >450 ms or presence of other of risk factors for torsade de pointes.
- Evidence for thyroid disease based on clinical and safety laboratory findings, including thyroid-stimulating hormone.
- Any laboratory value (from blood samples taken at the Enrollment Visit) meeting the following criteria:
- Out-of-reference range value for alanine transaminase, aspartate transaminase, alkaline phosphatase, total bilirubin, glucose (fasted), gamma-glutamyl transferase, serum creatinine, prothrombin time, and international normalized ratio.
- Exclusion range met for urinalysis or lactate dehydrogenase, potassium, total protein, sodium, calcium, hemoglobin, hematocrit, white blood cell count, or platelets.
- Out-of-reference range value for any other safety laboratory parameter that is judged as clinically relevant by the investigator.
- A single repeat laboratory test (for each out-of-range parameter) is allowed to rule out laboratory error.
- Positive or missing virus serology test (in blood sample taken at the Enrollment Visit) for human immunodeficiency virus Type 1 or Type 2 antibodies, hepatitis B surface antigen, (HBsAg), hepatitis B core antigen antibodies (anti-HBc), or hepatitis C virus antibodies.
- For women of childbearing potential only: positive or missing pregnancy test.
- Subject received IMP in another clinical trial (when assessing for Part 2, excludes IMP received in Part 1 of this trial) within 30 days before the Enrollment Visit. Depending on the nature of the previous IMP, a longer washout may be needed.
- Diseases or conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of orthostatic hypotension.
- History of, or at risk of seizures (i.e., head trauma, epilepsy in family history, unclear loss of consciousness).
- Definite or suspected hypersensitivity to the active substance or to any of the excipients of the IMP; especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists, acetaminophen or any excipients of the drug formulation.
- Evidence or history of alcohol or drug abuse including positive or missing alcohol breath test or drugs of abuse test.
- Unable to abstain from regular use of any medication, including herbal remedies or over-the-counter medication within 2 weeks prior to the Enrollment Visit and anticipated use during the course of the trial, excluding oral contraceptives in women of childbearing potential and topical medications or nasal sprays without systemic effect.
- Lactating or breastfeeding women.
- Habitually smoking more than 10 cigarettes, 2 cigars, or 2 pipes of tobacco per day within the last 6 months before enrollment in this trial.
- Unable to refrain from smoking during the stay at the trial site in each treatment period.
- Not willing or able to abstain from consumption of:
- Beverages or food containing methylxanthines (tea, coffee, cola, chocolate, etc.) from 48 hours prior to the planned first administration of IMP until discharge from the trial site in each treatment period.
- Beverages or food containing quinine (bitter lemon, tonic water), grapefruit juice (sweet or sour), Seville oranges, or alcohol from 72 hours prior to the planned first administration of IMP until discharge from the trial site in each treatment period.
- Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.
- Not able to communicate meaningfully with the trial site staff.
- Employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, as well as family members of the employees or the investigator.
- Blood loss of 500 mL or more within 45 days before enrollment in this trial.
- Unable to establish reliable venous access.
- Medical history of bronchial asthma, Addison's disease, prostatic hypertrophy, or urethral stricture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 mg (a New Abuse Deterrent Tablet and a Marketed Tablet) Under Fasted Conditions in Healthy Male and Female Adult Subjects
This clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of different amounts of tablets of a new and a marketed tablet formulation in healthy adults.
Part 1 is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral dose Phase I trial in 32 healthy male and female subjects. Part will consist of an Enrollment Visit, 4 treatment periods (each lasting approximately 90 hours), and a Final Examination. The treatment periods will be separated by a washout period each lasting at least 7 days.
Read more
Part 2 is optional and depending on pharmacokinetic data review after Part 1. It is a randomized, single-site, open-label, 2-treatment, 2-period crossover, single oral dose part in healthy male and female subjects. Part 2 will consist of an Enrollment Visit, 2 treatment periods (each lasting approximately 90 hours) and a Final Examination. The treatment periods will be separated by a washout period lasting at least 7 days.
Participants must fast for approximately 10 hours prior to administration of Investigational medicinal product (IMP) and until approximately 4 hours after the administration of the IMP.
- Conditions
- Opioid-Related Disorders, Pain, Acute, Pain, Postoperative
- Being tested
- GRT7014 - Abuse Deterrend Tablet, Norco 5Mg-325Mg Tablet
- Keywords
- Abuse deterrent formulation, Hydrocodone, Analgesics, Opioid, Narcotics
- Medical subject headings
- Opioid-Related Disorders, Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT7014 - Abuse Deterrend TabletDrug
Also called Hydrocodone bitartrate and acetaminophen
Single oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods.
Norco 5Mg-325Mg TabletDrug
Also called Hydrocodone bitartrate and acetaminophen
Single oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods.
| Study group | Role | What they receive |
|---|---|---|
| GRT7014 - 1 Tablet (Part 1) | Experimental | Abuse deterrent formulation of a fixed dose combination of hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet.
(GRT7014 - Abuse Deterrend Tablet) Receives: Drug: GRT7014 - Abuse Deterrend Tablet |
| GRT7014 - 10 Tablets (Part 1) | Experimental | Abuse deterrent formulation of a fixed dose combination of hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet.
(GRT7014 - Abuse Deterrend Tablet) Receives: Drug: GRT7014 - Abuse Deterrend Tablet |
| Norco - 1 Tablet (Part 1) | Active comparator | Norco fixed dose combination hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet (Norco 5Mg-325Mg Tablet). Receives: Drug: Norco 5Mg-325Mg Tablet |
| Norco - 10 Tablets (Part 1) | Active comparator | Norco fixed dose combination hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet (Norco 5Mg-325Mg Tablet). Receives: Drug: Norco 5Mg-325Mg Tablet |
| GRT7014 - 5 Tablets (Optional Part 2) | Experimental | Abuse deterrent formulation of a fixed dose combination of hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet.
(GRT7014 - Abuse Deterrend Tablet) Receives: Drug: GRT7014 - Abuse Deterrend Tablet |
| Norco - 5 Tablets (Optional Part 2) | Active comparator | Norco fixed dose combination hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet (Norco 5Mg-325Mg Tablet). Receives: Drug: Norco 5Mg-325Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) GRT7014 (1 and 10 Tablets)
The maximum plasma concentration of hydrocodone and of acetaminophen.
Measured: Between 0 hours and 72 hours
Area under the plasma concentration curve from timepoint 0 to t (AUC0-t) GRT7014 (1 and 10 Tablets)
The area under the plasma concentration curve of hydrocodone and of acetaminophen.
Measured: Between 0 hours and 72 hours
Area under the plasma concentration curve from timepoint 0 to infinity (AUC) GRT7014 (1 and 10 Tablets)
The area under the plasma concentration curve of hydrocodone and of acetaminophen.
Measured: Between 0 hours and 72 hours
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax) GRT7014 and Norco (1, 5 (optional) and 10 Tablets)
The maximum plasma concentration of hydrocodone and of acetaminophen.
Measured: Between 0 hours and 72 hours
Area under the plasma concentration curve from timepoint 0 to t (AUC0-t) GRT7014 and Norco (1, 5 (optional) and 10 Tablets)
The area under the plasma concentration curve of hydrocodone and of acetaminophen.
Measured: Between 0 hours and 72 hours
Area under the plasma concentration curve from timepoint 0 to infinity (AUC) GRT7014 and Norco (1, 5 (optional) and 10 Tablets)
The area under the plasma concentration curve of hydrocodone and of acetaminophen.
Measured: Between 0 hours and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startSep 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: program discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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
- Model description
- For Part 1, the randomization will be realized using a Williams Square with a 4x4 design. For the optional Part 2, a standard 2x2 crossover design will be applied.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137030
- Sponsor's protocol ID
- HP7014-02
- Other IDs
- U1111-1184-8922
- Status last verified
- Jul 2017
- First submitted
- 27 Apr 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details available at: http://www.grunenthal.com/grt-web/Grunenthal\_Group/Research\_Development/Grunenthal\_Clinical\_Trials/Data\_Sharing/296200025.jsp
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 mg (a New Abuse Deterrent Tablet and a Marketed Tablet) Under Fasted Conditions in Healthy Male and Female Adult Subjects
- ClinicalTrials.gov ID
- NCT03137030
- Acronym / sponsor ID
- HP7014-02
- Conditions
- Opioid-Related Disorders, Pain, Acute, Pain, Postoperative
- Keywords
- Abuse deterrent formulation, Hydrocodone, Analgesics, Opioid, Narcotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: program discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 2 May 2017 (actual)
- 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 clinical trial is being conducted to compare concentrations of hydrocodone and acetaminophen in the blood after administration of different amounts of tablets of a new and a marketed tablet formulation in healthy adults.
Part 1 is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral dose Phase I trial in 32 healthy male and female subjects. Part will consist of an Enrollment Visit, 4 treatment periods (each lasting approximately 90 hours), and a Final Examination. The treatment periods will be separated by a washout period each lasting at least 7 days.
Part 2 is optional and depending on pharmacokinetic data review after Part 1. It is a randomized, single-site, open-label, 2-treatment, 2-period crossover, single oral dose part in healthy male and female subjects. Part 2 will consist of an Enrollment Visit, 2 treatment periods (each lasting approximately 90 hours) and a Final Examination. The treatment periods will be separated by a washout period lasting at least 7 days.
Participants must fast for approximately 10 hours prior to administration of Investigational medicinal product (IMP) and until approximately 4 hours after the administration of the IMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- For Part 1, the randomization will be realized using a Williams Square with a 4x4 design. For the optional Part 2, a standard 2x2 crossover design will be applied.
| Arm | Type | Receives |
|---|---|---|
| GRT7014 - 1 Tablet (Part 1) | Experimental | Drug: GRT7014 - Abuse Deterrend TabletAbuse deterrent formulation of a fixed dose combination of hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet. (GRT7014 - Abuse Deterrend Tablet) |
| GRT7014 - 10 Tablets (Part 1) | Experimental | Drug: GRT7014 - Abuse Deterrend TabletAbuse deterrent formulation of a fixed dose combination of hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet. (GRT7014 - Abuse Deterrend Tablet) |
| Norco - 1 Tablet (Part 1) | Active comparator | Drug: Norco 5Mg-325Mg TabletNorco fixed dose combination hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet (Norco 5Mg-325Mg Tablet). |
| Norco - 10 Tablets (Part 1) | Active comparator | Drug: Norco 5Mg-325Mg TabletNorco fixed dose combination hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet (Norco 5Mg-325Mg Tablet). |
| GRT7014 - 5 Tablets (Optional Part 2) | Experimental | Drug: GRT7014 - Abuse Deterrend TabletAbuse deterrent formulation of a fixed dose combination of hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet. (GRT7014 - Abuse Deterrend Tablet) |
| Norco - 5 Tablets (Optional Part 2) | Active comparator | Drug: Norco 5Mg-325Mg TabletNorco fixed dose combination hydrocodone bitartrate 5 mg/acetaminophen 325 mg immediate release (IR) tablet (Norco 5Mg-325Mg Tablet). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects have given written informed consent to participate.
- Body mass index between 20 kg/m2 and 30 kg/m2 inclusive, with a minimal body weight of 60 kg.
- Subjects must be in good health as determined by the medical history, physical and laboratory examinations and must not show any clinically significant deviations from reference ranges as determined by 12-lead electrocardiogram (ECG), vital signs (blood pressure, pulse rate, respiratory rate), body temperature, oxygen saturation, and safety laboratory parameters (hematology, clinical chemistry, clotting, and urinalysis).
- From the first administration of IMP until at least 4 weeks (for women)/90 days (for men) after the Final Examination, subjects must agree to use highly effective contraception with a low failure rate defined as <1% per year.
- For female subjects of childbearing potential:
Key exclusion criteria (34 listed)
- Withdrawal of informed consent.
- Received forbidden medication or an investigational medical device since the Enrollment Visit.
- Any relevant deterioration in the health of the subject since the Enrollment Visit possibly impacting participation in the trial at the discretion of the investigator, including: adverse events; vital signs (relevant out-of-reference blood pressure or pulse rate if technical failure can be excluded and result is confirmed by at least 1 additional measurement); physical examination, 12-lead ECG (relevant QTc prolongation if result is confirmed by 1 additional ECG measurement and manual re-evaluation by the investigator); other safety parameters.
- Blood loss of 100 mL or more since enrollment in this trial (excluding blood taken for this trial).
- Resting pulse rate <50 beats per minute or >90 beats per minute.
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 |
|---|---|---|
| GRT7014 - Abuse Deterrend TabletAlso: Hydrocodone bitartrate and acetaminophenSingle oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods. | Drug | GRT7014 - 1 Tablet (Part 1), GRT7014 - 10 Tablets (Part 1), GRT7014 - 5 Tablets (Optional Part 2) |
| Norco 5Mg-325Mg TabletAlso: Hydrocodone bitartrate and acetaminophenSingle oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods. | Drug | Norco - 1 Tablet (Part 1), Norco - 10 Tablets (Part 1), Norco - 5 Tablets (Optional Part 2) |
Primary outcome
Maximum Plasma Concentration (Cmax) GRT7014 (1 and 10 Tablets)
Time frame: Between 0 hours and 72 hours
The maximum plasma concentration of hydrocodone and of acetaminophen.
Area under the plasma concentration curve from timepoint 0 to t (AUC0-t) GRT7014 (1 and 10 Tablets)
Time frame: Between 0 hours and 72 hours
The area under the plasma concentration curve of hydrocodone and of acetaminophen.
Area under the plasma concentration curve from timepoint 0 to infinity (AUC) GRT7014 (1 and 10 Tablets)
Time frame: Between 0 hours and 72 hours
The area under the plasma concentration curve of hydrocodone and of acetaminophen.
3 secondary outcomes
Maximum Plasma Concentration (Cmax) GRT7014 and Norco (1, 5 (optional) and 10 Tablets)
Time frame: Between 0 hours and 72 hours
Area under the plasma concentration curve from timepoint 0 to t (AUC0-t) GRT7014 and Norco (1, 5 (optional) and 10 Tablets)
Time frame: Between 0 hours and 72 hours
Area under the plasma concentration curve from timepoint 0 to infinity (AUC) GRT7014 and Norco (1, 5 (optional) and 10 Tablets)
Time frame: Between 0 hours and 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No. Details available at: http://www.grunenthal.com/grt-web/Grunenthal_Group/Research_Development/Grunenthal_Clinical_Trials/Data_Sharing/296200025.jsp
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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.
Grünenthal Study Director study director
Grünenthal GmbH
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 GRT7014 - Abuse Deterrend Tablet and Norco 5Mg-325Mg Tablet in people with Opioid-Related Disorders and Pain, Acute, run by Grünenthal GmbH 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 13 inclusion and 34 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: withdrawn, as of the sponsor's last update on 21 Jul 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum Plasma Concentration (Cmax) GRT7014 (1 and 10 Tablets) (time frame: Between 0 hours and 72 hours). The study lists 3 primary outcomes in all. 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 21 Jul 2017.