Acute PainPhase 1NCT03761407
A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body
A Phase 1 study testing 100 mg GRT0151Y, 125 mg GRT0151Y and 150 mg GRT0151Y in people with Acute Pain, run by Grünenthal GmbH at 1 site in France.
Trial summary
The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- 100 mg GRT0151Y, 125 mg GRT0151Y and 150 mg GRT0151Y
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2004to 26 Jul 2005
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female Caucasian.
- Age 40-65 years.
- Body mass index (BMI) between 18 and 30 kilograms/square meter (extremes included).
- Extensive Cytochrome P450 2D6 (CYP2D6) metabolizer.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory parameters (haematology, Blood sedimentation rate (BSR), clotting, bio-chemistry, urinalysis and virus serology). Minor deviations of laboratory values and ECG parameters from the normal range may be accepted, if judged by the investigator as clinically not relevant and if not considered to interfere with the study objectives.
- Adequate contraception. For females of childbearing potential (i.e. all females except surgically sterilized or at least 2 years postmenopausal) this is defined as follows: any form of hormonal contraception or intra-uterine device must be used, at least for 4 weeks prior to the first dosing AND she must give a consent to use an additional barrier contraception (condom or diaphragm) from 2 weeks prior to first dosing up to 4 weeks after the last dosing.
Show all 12Show fewer
- Written consent to participate in the study.
- Negative Human immunodeficiency virus (HIV)1/2-antibodies, Hepatitis B surface (HBs)-antigen, Hepatitis B core (HBc)-antibodies, Hepatitis C virus (HCV)-antibodies determined at screening examination.
- Negative drug abuse screening test determined at screening examination (the test will include screening for metamphetamine, opiate, cannabis, cocaine, amphetamine and benzodiazepine).
- Negative beta-human chorion gonadotropin test for females of childbearing potential determined at screening examination (the test is not necessary in females who are in post-menopausal state for at least 2 years or in females with status after surgical sterilisation).
- The participant must be able to tolerate the cold pressor test, i.e. he/she must be able to keep his/her hand for 120 seconds in cold water of about 2 degrees celsius.
- The participant must be able to undergo the procedure of pupillometry.
Who cannot join
- Pulse rate below 45 or above 100 Beats per minute (bpm). The measurement must be performed in supine position after a resting period of at least 5 minutes.
- Systolic blood pressure below 100 or above 160 Millimeter mercury (mmHg), diastolic blood pressure below 50 or above 100 mmHg. The measurement must be performed in supine position after a resting period of at least 5 minutes.
- History or presence of diseases or functional disorders of the Central nervous system (CNS), endocrinological system, gastrointestinal tract, hepatobiliary system, renal system, respiratory system or cardiovascular system or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Marked repolarisation abnormality (e.g. suspicious or definite congenital long QT syndrome) or co-medication that is known to influence cardiac repolarisation substantially.
- History of seizures or at risk (epilepsy in family anamnesis, unclear loss of consciousness), head trauma requiring hospitalization.
- Neurotic personality, psychiatric illness or suicide risk.
Show all 20Show fewer
- History of orthostatic hypotension.
- Bronchial asthma.
- Definite or suspected history of drug allergy or hypersensitivity.
- History of Raynaud´s disease or phenomenon.
- Malignancy.
- Participation in another clinical study within three month prior to the start of this study (exception: characterization of metabolizer status).
- Blood donation (more than 100 Milliliter(s) or a comparable blood loss within three month prior to the start of this study.
- Excessive consumption of food or beverages containing caffeine or other xanthines (more than 1000 Milliliter(s) coffee or equivalent per day) within two weeks prior to the start of this study.
- Evidence of alcohol, medication or drug abuse.
- Smokers who are not able to abstain from smoking during the hospitalisation.
- Intake of drugs that are inhibitors of CYP2D6 isoenzyme within the last 4 weeks prior to the start of this study. Use of any other medication within two weeks prior to the start of the study (self-medication or prescription), if not on a stable basis and known to interfere with study objectives.
- Known or suspected of not being able to comply with the study protocol or of not being able to communicate meaningfully with the investigator and staff.
- Opinion of the investigator the volunteer should not participate in the study.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase-I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Oral Doses of GRT0151Y in Healthy Male and Female Subjects
The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is excreted from the body)."
- Conditions
- Acute Pain
- Being tested
- 100 mg GRT0151Y, 125 mg GRT0151Y, 150 mg GRT0151Y, 225 mg GRT0151Y, Matching placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg GRT0151YDrug
100 mg capsule (1 x 100 mg capsule)
125 mg GRT0151YDrug
125 mg (1 x 100 mg capsule and 1 x 25 mg capsule)
150 mg GRT0151YDrug
150 mg (1 x 100 mg capsule and 1 x 50 mg capsule)
225 mg GRT0151YDrug
Day 1: 150 mg (1 x 100 mg capsule and 1 x 50 mg capsule) Day 2 - 5: 225 mg (2 x 100 mg capsules and 1 x 25 mg capsule)
Matching placeboDrug
Matching placebo capsules using the same dosing regimen as defined in the treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (100 mg GRT0151Y) | Experimental | The dose of 100 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the treatment regimen will be changed to a triple daily (t.i.d) medication with 100 mg. On Day 5 the last dose of 100 mg will be administered in the morning.
Matching placebo using the same dosing regimen as defined in the treatment group. Receives: Drug: 100 mg GRT0151Y; Drug: Matching placebo |
| Group 2 (125 mg GRT0151Y) | Experimental | The dose of 125 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the treatment regimen will be changed to a triple daily (t.i.d) medication with 125 mg. On Day 5 the last dose of 125 mg will be administered in the morning.
Matching placebo using the same dosing regimen as defined in the treatment group Receives: Drug: 125 mg GRT0151Y; Drug: Matching placebo |
| Group 3 (150 mg GRT0151Y) | Experimental | The dose of 150 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the treatment regimen will be changed to a triple daily (t.i.d) medication with 150 mg. On Day 5 the last dose of 150 mg will be administered in the morning.
Matching placebo using the same dosing regimen as defined in the treatment group Receives: Drug: 150 mg GRT0151Y; Drug: Matching placebo |
| Group 4 (225 mg GRT0151Y) | Experimental | The dose of 150 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the dose of 225 mg will be administered twice (b.i.d.). On Day 5 the last dose of 225 mg will be administered in the morning.
Matching placebo using the same dosing regimen as defined in the treatment group Receives: Drug: 225 mg GRT0151Y; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events.
Number of adverse events and number of participants with adverse events.
Measured: From the first IMP administration (Day 1) to the Final Examination (Day 4 to 11 after last period).
Secondary outcomes (22)
Pupillometry parameter: Initial pupil diameter
Pupil size (in mm) will be measured using a Compact Integrated Pupillograph (CIP). Measurements will be performed always in the same eye of the individual (preferably the left eye). The measurements will be performed under standard low-light conditions (10-15 lux).
Measured: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Pupillometry parameter: Amplitude of constriction
Amplitude of constriction (difference between initial pupil diameter and minimum pupil diameter [mm])
Measured: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Pupillometry parameter: Onset latency of miosis
Onset latency of miosis (the time between begin of light stimulus and the onset of constriction [ms])
Measured: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Pupillometry parameter: Constriction time
Constriction time (time for maximum pupil contraction [s])
Measured: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Minimum plasma concentration during dosing interval τ at steady-state (Css,min)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Maximum plasma concentration during dosing interval τ at steady-state (Css,max)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Time to reach maximum plasma concentration during dosing interval τ at steady-state (tss,max)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Area under the concentration vs. time curve after the last dose (AUC)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Average plasma concentration during dosing interval τ at steady-state (Css,ave)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Peak-trough fluctuation at steady-state (PTF%)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Rate constant for the terminal log-linear phase of the concentration time data, computed as the negative slope of the regression line for the terminal linear phase of the logarithmic concentration versus time plot (λss,z)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Half-life for the terminal log-linear phase of the concentration time data (tss,1/2,z)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Apparent terminal half-life after last dose (t1/2,Z)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Apparent terminal elimination rate constant after last dose (λz)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Area under the concentration vs. time curve in dosing interval τ at steady-state (AUCss,τ)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Extrapolated part to infinity of AUCss at steady-state (AUCextr)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Extrapolated part to infinity of AUCss in percent at steady-state (AUC%extr)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Area under the concentration-time data for dosing interval τ (AUC0-τ)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Total mean time in the total volume of distribution (MRTvsys)
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Relative total clearance (CL/F)ss
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Relative volume of distribution for the terminal log-linear phase of the concentration time data (Vz/F)ss
Measured: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Cold Pressor Test (CPT) (AUC of pain assessment)
The dominant hand will be plunged into a 1-3 degrees Celsius circulating cold water quench for 2 minutes. By using a computer mouse with the other hand, the participant adjusted a visual analogue scale on a computer screen facing them. The scale was labelled "no pain" at one end and "maximum pain" at the other end.
Measured: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1, 4, 11, 23, 35 and 47 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start30 Dec 2004
- Primary completion26 Jul 2005
- Study completion26 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Twelve volunteers (6 males and 6 females) per dose group will be randomly assigned to two treatment sequences (placebo-verum and verum-placebo, within dose-group randomized) in a ratio of 1:1. There will be a washout period of 7 to 11 days between the treatment sequences.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT03761407
- Sponsor's protocol ID
- HP0151Y/09
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Oral Doses of GRT0151Y in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03761407
- Acronym / sponsor ID
- HP0151Y/09
- Conditions
- Acute Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2004 (actual)
- Primary completion
- 26 Jul 2005 (actual)
- Study completion
- 26 Jul 2005 (actual)
- First posted
- 3 Dec 2018 (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.
The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is excreted from the body)."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Twelve volunteers (6 males and 6 females) per dose group will be randomly assigned to two treatment sequences (placebo-verum and verum-placebo, within dose-group randomized) in a ratio of 1:1. There will be a washout period of 7 to 11 days between the treatment sequences.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (100 mg GRT0151Y) | Experimental | Drug: 100 mg GRT0151Y, Drug: Matching placeboThe dose of 100 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the treatment regimen will be changed to a triple daily (t.i.d) medication with 100 mg. On Day 5 the last dose of 100 mg will be administered in the morning. Matching placebo using the same dosing regimen as defined in the treatment group. |
| Group 2 (125 mg GRT0151Y) | Experimental | Drug: 125 mg GRT0151Y, Drug: Matching placeboThe dose of 125 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the treatment regimen will be changed to a triple daily (t.i.d) medication with 125 mg. On Day 5 the last dose of 125 mg will be administered in the morning. Matching placebo using the same dosing regimen as defined in the treatment group |
| Group 3 (150 mg GRT0151Y) | Experimental | Drug: 150 mg GRT0151Y, Drug: Matching placeboThe dose of 150 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the treatment regimen will be changed to a triple daily (t.i.d) medication with 150 mg. On Day 5 the last dose of 150 mg will be administered in the morning. Matching placebo using the same dosing regimen as defined in the treatment group |
| Group 4 (225 mg GRT0151Y) | Experimental | Drug: 225 mg GRT0151Y, Drug: Matching placeboThe dose of 150 mg will be administered twice (b.i.d.) on Day 1 (titration day). On Days 2, 3 and 4, the dose of 225 mg will be administered twice (b.i.d.). On Day 5 the last dose of 225 mg will be administered in the morning. Matching placebo using the same dosing regimen as defined in the treatment group |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female Caucasian.
- Age 40-65 years.
- Body mass index (BMI) between 18 and 30 kilograms/square meter (extremes included).
- Extensive Cytochrome P450 2D6 (CYP2D6) metabolizer.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory parameters (haematology, Blood sedimentation rate (BSR), clotting, bio-chemistry, urinalysis and virus serology). Minor deviations of laboratory values and ECG parameters from the normal range may be accepted, if judged by the investigator as clinically not relevant and if not considered to interfere with the study objectives.
Key exclusion criteria (20 listed)
- Pulse rate below 45 or above 100 Beats per minute (bpm). The measurement must be performed in supine position after a resting period of at least 5 minutes.
- Systolic blood pressure below 100 or above 160 Millimeter mercury (mmHg), diastolic blood pressure below 50 or above 100 mmHg. The measurement must be performed in supine position after a resting period of at least 5 minutes.
- History or presence of diseases or functional disorders of the Central nervous system (CNS), endocrinological system, gastrointestinal tract, hepatobiliary system, renal system, respiratory system or cardiovascular system or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Marked repolarisation abnormality (e.g. suspicious or definite congenital long QT syndrome) or co-medication that is known to influence cardiac repolarisation substantially.
- History of seizures or at risk (epilepsy in family anamnesis, unclear loss of consciousness), head trauma requiring hospitalization.
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 |
|---|---|---|
| 100 mg GRT0151Y100 mg capsule (1 x 100 mg capsule) | Drug | Group 1 (100 mg GRT0151Y) |
| 125 mg GRT0151Y125 mg (1 x 100 mg capsule and 1 x 25 mg capsule) | Drug | Group 2 (125 mg GRT0151Y) |
| 150 mg GRT0151Y150 mg (1 x 100 mg capsule and 1 x 50 mg capsule) | Drug | Group 3 (150 mg GRT0151Y) |
| 225 mg GRT0151YDay 1: 150 mg (1 x 100 mg capsule and 1 x 50 mg capsule) Day 2 - 5: 225 mg (2 x 100 mg capsules and 1 x 25 mg capsule) | Drug | Group 4 (225 mg GRT0151Y) |
| Matching placeboMatching placebo capsules using the same dosing regimen as defined in the treatment groups. | Drug | Group 1 (100 mg GRT0151Y), Group 2 (125 mg GRT0151Y), Group 3 (150 mg GRT0151Y), Group 4 (225 mg GRT0151Y) |
Primary outcome
Incidence of adverse events.
Time frame: From the first IMP administration (Day 1) to the Final Examination (Day 4 to 11 after last period).
Number of adverse events and number of participants with adverse events.
22 secondary outcomes
Pupillometry parameter: Initial pupil diameter
Time frame: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Pupillometry parameter: Amplitude of constriction
Time frame: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Pupillometry parameter: Onset latency of miosis
Time frame: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Pupillometry parameter: Constriction time
Time frame: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1 hour, 4, 11, 23, 35 and 47 hours
Minimum plasma concentration during dosing interval τ at steady-state (Css,min)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Maximum plasma concentration during dosing interval τ at steady-state (Css,max)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Time to reach maximum plasma concentration during dosing interval τ at steady-state (tss,max)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Area under the concentration vs. time curve after the last dose (AUC)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Average plasma concentration during dosing interval τ at steady-state (Css,ave)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Peak-trough fluctuation at steady-state (PTF%)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Rate constant for the terminal log-linear phase of the concentration time data, computed as the negative slope of the regression line for the terminal linear phase of the logarithmic concentration versus time plot (λss,z)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Half-life for the terminal log-linear phase of the concentration time data (tss,1/2,z)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Apparent terminal half-life after last dose (t1/2,Z)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Apparent terminal elimination rate constant after last dose (λz)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Area under the concentration vs. time curve in dosing interval τ at steady-state (AUCss,τ)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Extrapolated part to infinity of AUCss at steady-state (AUCextr)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Extrapolated part to infinity of AUCss in percent at steady-state (AUC%extr)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Area under the concentration-time data for dosing interval τ (AUC0-τ)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Total mean time in the total volume of distribution (MRTvsys)
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Relative total clearance (CL/F)ss
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Relative volume of distribution for the terminal log-linear phase of the concentration time data (Vz/F)ss
Time frame: predose on Day 1, during 4 consecutive days of multiple dosing and up to 72 hours after the last dosing on Day 5
Cold Pressor Test (CPT) (AUC of pain assessment)
Time frame: Day 1 at 0 hour, 4, 11 and 23 hours, on Day 2 at 11 and 23 hours and on Day 5 at 0 hour, 1, 4, 11, 23, 35 and 47 hours.
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 3 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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 100 mg GRT0151Y, 125 mg GRT0151Y and 150 mg GRT0151Y in people with Acute Pain, run by Grünenthal GmbH at 1 site in France.
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 12 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 3 Dec 2018. 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 France. 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?
Incidence of adverse events. (time frame: From the first IMP administration (Day 1) to the Final Examination (Day 4 to 11 after last period).). 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 3 Dec 2018.