Prolonged QTc IntervalPhase 1NCT03958123
Evaluation of the Effects of Multiple Doses of Cebranopadol on the Electrical Activity of the Heart in Healthy Subjects
A Phase 1 study testing 100 μg cebranopadol, 200 μg cebranopadol and 400 μg cebranopadol in people with Prolonged QTc Interval and Pharmacokinetic, run by Tris Pharma, Inc. at 1 site in United States.
Trial summary
The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the electrical activity of the heart in healthy participants. The study consisted of a screening period within 21 days before the first dose of investigational medicinal product (IMP) (between Day -25 and Day -4) during which informed… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prolonged QTc Interval, Pharmacokinetic
- What is being tested?
- 100 μg cebranopadol, 200 μg cebranopadol and 400 μg cebranopadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2013to 27 Nov 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent form (ICF) and have the mental capability to understand it.
- Be a healthy male or female, aged 18 through 45 years, inclusive.
- If female, have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -4.
- If male, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide or condom plus spermicide) and not have their partners become pregnant throughout the study, or have been sterilized for at least 1 year (with supporting documentation of the absence of sperm in the ejaculate postvasectomy).
- If female of childbearing potential, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide, condom plus spermicide, or nonhormonal intrauterine device) and not become pregnant throughout the study. Females who are at least 2-years postmenopausal (with supporting documentation from an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy (with supporting documentation from the physician who performed the surgery) will not be considered to be of childbearing potential.
- Be nonsmoking (never smoked or have not smoked within the previous 2 years).
- Have a body mass index (BMI) greater than or equal to 18 kilograms per square meter and less than or equal to 30 kilograms per square meter.
- Have a sitting pulse rate greater than or equal to 50 beats per minute (bpm) and less than or equal to 100 bpm during the vital sign assessment at screening.
Who cannot join
- Known hypersensitivity to cebranopadol, other opioids, or moxifloxacin or other fluoroquinolone antibiotics.
- Clinically significant disease state, in the opinion of the examining physician, in any body system.
- Sitting systolic blood pressure (BP) greater than or equal to 140 millimeters mercury (mm Hg) or less than or equal to 90 mm Hg or sitting diastolic BP greater than or equal to 90 mm Hg or less than or equal to 50 mm Hg at screening.
- Abnormal electrocardiogram (ECG) results thought to be potentially clinically significant (PCS), or QT prolongation (QTcF greater than or equal to 450 milliseconds (msec) or uncorrected QT greater than or equal to 500 msec) according to the Investigator.
- History of cardiovascular disease including but not limited to long QT syndrome (or family history of long QT syndrome), cardiac arrhythmia, orthostatic hypotension, and coronary artery or valvular disease.
- Positive test results for anti-human immunodeficiency virus type 1, hepatitis B surface antigen, hepatitis B core antibodies, or anti-hepatitis C virus at screening.
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- Abnormal and clinically significant results on medical history, physical examination, serum chemistry, hematology, or urinalysis.
- History of alcohol or other substance abuse within the previous 5 years.
- Positive urine drug screen test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, cannabinoids, opiates, phencyclidine, or cotinine at screening or Day -4.
- Have taken opioids within the past 1 month.
- Participation in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 60 days of investigational product administration.
- Participation in a blood or plasma donation program within 60 or 30 days, respectively, of investigational product administration.
- Consumption of caffeine products within 48 hours or any grapefruit-containing products or Seville oranges within 14 days or consumption of alcohol or poppy seeds within 72 hours before administration of investigational product.
- Consumption of beverages or food containing quinine (bitter lemon, tonic water) within 14 days before administration of investigational product until discharge from the study center.
- Have any clinical condition that might affect the absorption, distribution, biotransformation, or excretion of cebranopadol or moxifloxacin.
- Employee, or immediate relative of an employee, of Forest Laboratories, Inc. or Grünenthal GmbH, any of its affiliates or partners, or the study center.
- Taken any concomitant medications (including over-the-counter medications) within 14 days or hormonal drug products within 30 days before administration of investigational product.
- Previously taken cebranopadol or previously participated in an investigational study of cebranopadol.
- Breastfeeding.
- Responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) that indicate any current suicidal ideation or a history of active suicidal ideation or suicide attempts.
- Suicidal risk based on the opinion of the principal investigator (or appropriately trained designee).
Trial locations and contacts
1 site in 1 country.
United States1 site
US001 Contract research organization
West Bend, Wisconsin, 53095
About this study
Official title: Evaluation of the Effects of Multiple Therapeutic and Supratherapeutic Doses of Cebranopadol on Cardiac Repolarization in Healthy Subjects
The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the electrical activity of the heart in healthy participants.
The study consisted of a screening period within 21 days before the first dose of investigational medicinal product (IMP) (between Day -25 and Day -4) during which informed consent was obtained and the general suitability of the participants for the trial was assessed according to the inclusion/exclusion criteria.
Read more
Participants were confined to the trial site from 4 days before first IMP dosing on Day 1 to 4 days after last IMP dosing on Day 30. During this period, multiple-doses of cebranopadol or matching placebo and a single-dose of moxifloxacin or matching placebo were administered. Moxifloxacin was used as a positive control. It has consistently shown that it has an effect on the heart rhythm. Continuous 12-lead ECGs were recorded at defined time points. Multiple blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory monitoring (hematology, chemistry, and urinalysis). Additional safety evaluations included recording of adverse events, vital signs (systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature, and weight), oxygen saturation, standard 12-lead ECG, Clinical Opiate Withdrawal Scale (COWS) assessment, and Columbia-Suicide Severity Rating Scale (C-SSRS) assessment.
An End-of-Trial Visit was performed on Day 34, or within 7 days after the last pharmacokinetic sample on Day 34, or at early withdrawal.
- Conditions
- Prolonged QTc Interval, Pharmacokinetic
- Being tested
- 100 μg cebranopadol, 200 μg cebranopadol, 400 μg cebranopadol, Placebo to cebranopadol encapsulated tablets, 400 mg Moxifloxacin
- Keywords
- QT/QTc Interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 μg cebranopadolDrug
Encapsulated 100 μg cebranopadol tablet.
200 μg cebranopadolDrug
Encapsulated 200 μg cebranopadol tablet.
400 μg cebranopadolDrug
Encapsulated 400 μg cebranopadol tablet.
Placebo to cebranopadol encapsulated tabletsDrug
Matching placebo to cebranopadol encapsulated tablet.
400 mg MoxifloxacinDrug
Encapsulated 400 mg moxifloxacin tablet.
Placebo to moxifloxacin encapsulated tabletsDrug
Matching placebo to moxifloxacin (400 mg) encapsulated tablet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1: Cebranopadol | Experimental | Supratherapeutic dose (1600 μg) of cebranopadol:
Participants received placebo once a day for 2 days (Days -3 and -1); 200 μg of cebranopadol once a day for 3 days; 400 μg once a day for 3 days; 600 μg once a day for 3 days; 900 μg once a day for 3 days; 1300 μg once a day for 3 days; 1600 μg once a day for 14 days; and placebo once a day on the last dosing day.
Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days. Participants received four encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. Receives: Drug: 100 μg cebranopadol; Drug: 200 μg cebranopadol; Drug: 400 μg cebranopadol; Drug: Placebo to cebranopadol encapsulated tablets; Drug: Placebo to moxifloxacin encapsulated tablets |
| Treatment Group 2: Cebranopadol | Experimental | Therapeutic dose (600 μg) of cebranopadol:
Participants received placebo once a day for the first 11 days (Days -3, -1 and 1-9); 200 μg of cebranopadol once a day for 3 days; 400 μg once a day for 3 days; 600 μg once a day for 14 days; and placebo once a day on the last dosing day.
Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days. Participants received 4 encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. Receives: Drug: 200 μg cebranopadol; Drug: 400 μg cebranopadol; Drug: Placebo to cebranopadol encapsulated tablets; Drug: Placebo to moxifloxacin encapsulated tablets |
| Treatment Group 3A: Placebo and Moxifloxacin | Experimental | Placebo / Moxifloxacin:
Participants received placebo once a day for 31 days (Days -3, -1 and 1-29) and moxifloxacin 400 mg once on the last dosing day. Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days.
Participants received 4 encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. Receives: Drug: Placebo to cebranopadol encapsulated tablets; Drug: 400 mg Moxifloxacin; Drug: Placebo to moxifloxacin encapsulated tablets |
| Treatment Group 3B: Moxifloxacin and Placebo | Experimental | Moxifloxacin / Placebo:
Participants received placebo once a day for 2 days (Days -3 and -1); moxifloxacin 400 mg once for 1 day; and placebo once a day for the following 29 days. Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days.
Participants received four encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. Receives: Drug: Placebo to cebranopadol encapsulated tablets; Drug: 400 mg Moxifloxacin; Drug: Placebo to moxifloxacin encapsulated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcNi change from time-matched baseline measurement on Day -1 to Day 29 - supported sitting position
Largest time-matched mean difference between cebranopadol and placebo in supported sitting QT interval corrected for heart rate using an individual correction (QTcNi) change from time-matched baseline measurement on Day -1.
Measured: Day -1 up to Day 29
Secondary outcomes (40)
QTcNi change from time-matched baseline measurement on Day -1 to Day 29 - supine position
Largest time-matched mean difference between cebranopadol and placebo in supine QTcNi change from time-matched baseline measurement on Day -1.
Measured: Day -1 up to Day 29
QTcF change from time-matched baseline measurement on Day -1 to Day 29 - sitting position
Largest time-matched mean difference between cebranopadol and placebo in supported sitting QT interval corrected for heart rate using the Fridericia formula (QTcF) change from time-matched baseline measurement on Day -1.
Measured: Day -1 up to Day 29
QTcF change from time-matched baseline measurement on Day -1 to Day 29 - supine position
Largest time-matched mean difference between cebranopadol and placebo in supine QTcF change from time-matched baseline measurement on Day -1.
Measured: Day -1 up to Day 29
Pharmacokinetic parameter: AUC0-tau,ss of cebranopadol
Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval, tau, at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-tau,ss of M2 (7-hydroxy-GRT6005)
Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval, tau, at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-tau,ss of M3 (N-desmethyl-GRT6005)
Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval, tau, at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-tau,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval, tau, at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of cebranopadol
Area under the plasma concentration versus time curve from time 0 to time t after the last dose. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of M2 (7-hydroxy-GRT6005)
Area under the plasma concentration versus time curve from time 0 to time t after the last dose. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of M3 (N-desmethyl-GRT6005)
Area under the plasma concentration versus time curve from time 0 to time t after the last dose. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of M6 (7-hydroxy N-desmethyl-GRT6005)
Area under the plasma concentration versus time curve from time 0 to time t after the last dose. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of cebranopadol
Average plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of M2 (7-hydroxy-GRT6005)
Average plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of M3 (N-desmethyl-GRT6005)
Average plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Average plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of cebranopadol
Maximum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of M2 (7-hydroxy-GRT6005)
Maximum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of M3 (N-desmethyl-GRT6005)
Maximum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Maximum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of cebranopadol
Minimum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of M2 (7-hydroxy-GRT6005)
Minimum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of M3 (N-desmethyl-GRT6005)
Minimum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Minimum plasma drug concentration at steady state. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of cebranopadol
The difference between Cmin and Cmax standardized to Cavg, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of M2 (7-hydroxy-GRT6005)
The difference between Cmin and Cmax standardized to Cavg, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of M3 (N-desmethyl-GRT6005)
The difference between Cmin and Cmax standardized to Cavg, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of M6 (7-hydroxy N-desmethyl-GRT6005)
The difference between Cmin and Cmax standardized to Cavg, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of cebranopadol
The difference between Cmin and Cmax standardized to Cmin, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of M2 (7-hydroxy-GRT6005)
The difference between Cmin and Cmax standardized to Cmin, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of M3 (N-desmethyl-GRT6005)
The difference between Cmin and Cmax standardized to Cmin, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of M6 (7-hydroxy N-desmethyl-GRT6005)
The difference between Cmin and Cmax standardized to Cmin, within 1 dosing interval. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of cebranopadol
Time of maximum plasma drug concentration. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of M2 (7-hydroxy-GRT6005)
Time of maximum plasma drug concentration. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of M3 (N-desmethyl-GRT6005)
Time of maximum plasma drug concentration. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of M6 (7-hydroxy N-desmethyl-GRT6005)
Time of maximum plasma drug concentration. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for cebranopadol and its metabolites were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-inf of moxifloxacin
Area under the plasma concentration versus time curve from time 0 to infinity. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for moxifloxacin were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of moxifloxacin
Area under the first moment of the plasma concentration versus time curve from time 0 to time t. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for moxifloxacin were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax of moxifloxacin
Maximum plasma drug concentration. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for moxifloxacin were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: t1/2 of moxifloxacin
Terminal half-life. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for moxifloxacin were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of moxifloxacin
Time of maximum plasma drug concentration. PK blood samples were collected before administration of the IMP and up to 96 hours after dosing; 32 PK blood samples were obtained from each participant. Plasma concentrations for moxifloxacin were determined using validated high-performance liquid chromatography-tandem mass spectrometry bioanalytical assays.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 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 posted21 May 2019
- Study start10 Jul 2013
- Primary completion27 Nov 2013
- Study completion27 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged QTc IntervalStudies 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
- Model description
- Participants were randomized to 1 of 4 treatment groups on Day -3: The study included a nested cross-over design for participants in treatment group 3 (A, B).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Study Director Grünenthal, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958123
- Sponsor's protocol ID
- GRT-PK-12
- Status last verified
- Jul 2021
- First submitted
- 20 May 2019
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Multiple Therapeutic and Supratherapeutic Doses of Cebranopadol on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03958123
- Acronym / sponsor ID
- GRT-PK-12
- Conditions
- Prolonged QTc Interval, Pharmacokinetic
- Keywords
- QT/QTc Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- 10 Jul 2013 (actual)
- Primary completion
- 27 Nov 2013 (actual)
- Study completion
- 27 Nov 2013 (actual)
- First posted
- 21 May 2019 (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 objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the electrical activity of the heart in healthy participants.
The study consisted of a screening period within 21 days before the first dose of investigational medicinal product (IMP) (between Day -25 and Day -4) during which informed consent was obtained and the general suitability of the participants for the trial was assessed according to the inclusion/exclusion criteria.
Participants were confined to the trial site from 4 days before first IMP dosing on Day 1 to 4 days after last IMP dosing on Day 30. During this period, multiple-doses of cebranopadol or matching placebo and a single-dose of moxifloxacin or matching placebo were administered. Moxifloxacin was used as a positive control. It has consistently shown that it has an effect on the heart rhythm. Continuous 12-lead ECGs were recorded at defined time points. Multiple blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory monitoring (hematology, chemistry, and urinalysis). Additional safety evaluations included recording of adverse events, vital signs (systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature, and weight), oxygen saturation, standard 12-lead ECG, Clinical Opiate Withdrawal Scale (COWS) assessment, and Columbia-Suicide Severity Rating Scale (C-SSRS) assessment.
An End-of-Trial Visit was performed on Day 34, or within 7 days after the last pharmacokinetic sample on Day 34, or at early withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants were randomized to 1 of 4 treatment groups on Day -3: The study included a nested cross-over design for participants in treatment group 3 (A, B).
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1: Cebranopadol | Experimental | Drug: 100 μg cebranopadol, Drug: 200 μg cebranopadol, Drug: 400 μg cebranopadol, Drug: Placebo to cebranopadol encapsulated tablets, Drug: Placebo to moxifloxacin encapsulated tabletsSupratherapeutic dose (1600 μg) of cebranopadol: Participants received placebo once a day for 2 days (Days -3 and -1); 200 μg of cebranopadol once a day for 3 days; 400 μg once a day for 3 days; 600 μg once a day for 3 days; 900 μg once a day for 3 days; 1300 μg once a day for 3 days; 1600 μg once a day for 14 days; and placebo once a day on the last dosing day. Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days. Participants received four encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. |
| Treatment Group 2: Cebranopadol | Experimental | Drug: 200 μg cebranopadol, Drug: 400 μg cebranopadol, Drug: Placebo to cebranopadol encapsulated tablets, Drug: Placebo to moxifloxacin encapsulated tabletsTherapeutic dose (600 μg) of cebranopadol: Participants received placebo once a day for the first 11 days (Days -3, -1 and 1-9); 200 μg of cebranopadol once a day for 3 days; 400 μg once a day for 3 days; 600 μg once a day for 14 days; and placebo once a day on the last dosing day. Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days. Participants received 4 encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. |
| Treatment Group 3A: Placebo and Moxifloxacin | Experimental | Drug: Placebo to cebranopadol encapsulated tablets, Drug: 400 mg Moxifloxacin, Drug: Placebo to moxifloxacin encapsulated tabletsPlacebo / Moxifloxacin: Participants received placebo once a day for 31 days (Days -3, -1 and 1-29) and moxifloxacin 400 mg once on the last dosing day. Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days. Participants received 4 encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. |
| Treatment Group 3B: Moxifloxacin and Placebo | Experimental | Drug: Placebo to cebranopadol encapsulated tablets, Drug: 400 mg Moxifloxacin, Drug: Placebo to moxifloxacin encapsulated tabletsMoxifloxacin / Placebo: Participants received placebo once a day for 2 days (Days -3 and -1); moxifloxacin 400 mg once for 1 day; and placebo once a day for the following 29 days. Participants received capsules under fasting conditions on Days -3, -1, 1, 29 and 30, and under fed conditions on all other dosing days. Participants received four encapsulated cebranopadol/ placebo tablets and 1 encapsulated moxifloxacin/ placebo tablet (5 capsules in total) on Day -3, Day -1, and from Day 1 to Day 30. Capsules were taken with 240 mL of water. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Sign the informed consent form (ICF) and have the mental capability to understand it.
- Be a healthy male or female, aged 18 through 45 years, inclusive.
- If female, have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -4.
- If male, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide or condom plus spermicide) and not have their partners become pregnant throughout the study, or have been sterilized for at least 1 year (with supporting documentation of the absence of sperm in the ejaculate postvasectomy).
- If female of childbearing potential, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide, condom plus spermicide, or nonhormonal intrauterine device) and not become pregnant throughout the study. Females who are at least 2-years postmenopausal (with supporting documentation from an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy (with supporting documentation from the physician who performed the surgery) will not be considered to be of childbearing potential.
Key exclusion criteria (21 listed)
- Known hypersensitivity to cebranopadol, other opioids, or moxifloxacin or other fluoroquinolone antibiotics.
- Clinically significant disease state, in the opinion of the examining physician, in any body system.
- Sitting systolic blood pressure (BP) greater than or equal to 140 millimeters mercury (mm Hg) or less than or equal to 90 mm Hg or sitting diastolic BP greater than or equal to 90 mm Hg or less than or equal to 50 mm Hg at screening.
- Abnormal electrocardiogram (ECG) results thought to be potentially clinically significant (PCS), or QT prolongation (QTcF greater than or equal to 450 milliseconds (msec) or uncorrected QT greater than or equal to 500 msec) according to the Investigator.
- History of cardiovascular disease including but not limited to long QT syndrome (or family history of long QT syndrome), cardiac arrhythmia, orthostatic hypotension, and coronary artery or valvular disease.
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 μg cebranopadolEncapsulated 100 μg cebranopadol tablet. | Drug | Treatment Group 1: Cebranopadol |
| 200 μg cebranopadolEncapsulated 200 μg cebranopadol tablet. | Drug | Treatment Group 1: Cebranopadol, Treatment Group 2: Cebranopadol |
| 400 μg cebranopadolEncapsulated 400 μg cebranopadol tablet. | Drug | Treatment Group 1: Cebranopadol, Treatment Group 2: Cebranopadol |
| Placebo to cebranopadol encapsulated tabletsMatching placebo to cebranopadol encapsulated tablet. | Drug | Treatment Group 1: Cebranopadol, Treatment Group 2: Cebranopadol, Treatment Group 3A: Placebo and Moxifloxacin, Treatment Group 3B: Moxifloxacin and Placebo |
| 400 mg MoxifloxacinEncapsulated 400 mg moxifloxacin tablet. | Drug | Treatment Group 3A: Placebo and Moxifloxacin, Treatment Group 3B: Moxifloxacin and Placebo |
| Placebo to moxifloxacin encapsulated tabletsMatching placebo to moxifloxacin (400 mg) encapsulated tablet. | Drug | Treatment Group 1: Cebranopadol, Treatment Group 2: Cebranopadol, Treatment Group 3A: Placebo and Moxifloxacin, Treatment Group 3B: Moxifloxacin and Placebo |
Primary outcome
QTcNi change from time-matched baseline measurement on Day -1 to Day 29 - supported sitting position
Time frame: Day -1 up to Day 29
Largest time-matched mean difference between cebranopadol and placebo in supported sitting QT interval corrected for heart rate using an individual correction (QTcNi) change from time-matched baseline measurement on Day -1.
40 secondary outcomes
QTcNi change from time-matched baseline measurement on Day -1 to Day 29 - supine position
Time frame: Day -1 up to Day 29
QTcF change from time-matched baseline measurement on Day -1 to Day 29 - sitting position
Time frame: Day -1 up to Day 29
QTcF change from time-matched baseline measurement on Day -1 to Day 29 - supine position
Time frame: Day -1 up to Day 29
Pharmacokinetic parameter: AUC0-tau,ss of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-tau,ss of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-tau,ss of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-tau,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cav,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmin,ss of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Fluctuation of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Swing of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of cebranopadol
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of M2 (7-hydroxy-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of M3 (N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of M6 (7-hydroxy N-desmethyl-GRT6005)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-inf of moxifloxacin
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: AUC0-t of moxifloxacin
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: Cmax of moxifloxacin
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: t1/2 of moxifloxacin
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 hours post-dose
Pharmacokinetic parameter: tmax of moxifloxacin
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 14, 24, 48, 72, and 96 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 15 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Study Director Grünenthal 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 μg cebranopadol, 200 μg cebranopadol and 400 μg cebranopadol in people with Prolonged QTc Interval and Pharmacokinetic, run by Tris Pharma, 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 8 inclusion and 21 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 15 Jul 2021. 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?
QTcNi change from time-matched baseline measurement on Day -1 to Day 29 - supported sitting position (time frame: Day -1 up to Day 29). 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 15 Jul 2021.