PharmacokineticPhase 1NCT03979989
Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)
A Phase 1 study testing Tapentadol IR capsule and Omeprazole capsule in people with Pharmacokinetic, run by Grünenthal GmbH at 1 site in Belgium.
Trial summary
This was a single center, open-label, two-way crossover, drug-drug-interaction study to determine the effect of multiple dosing of omeprazole on 4 consecutive days on the pharmacokinetics of a single dose of an immediate-release capsule of CG5503 (tapentadol) in healthy participants. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic
- What is being tested?
- Tapentadol IR capsule and Omeprazole capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Sep 2005to 16 Nov 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman, between 25 and 55 years of age, inclusive.
- Body mass index between 20 and 28 kg/square meter, inclusive, with a minimum body weight of 50 kg.
- Signed the informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day -1 of Treatment Period 1.
- Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters (serum chemistry, serology, hematology, and urinalysis) performed within 21 days before administration of the first dose of study drug. NOTE: If the results of the chemistry, hematology, or urinalysis testing are not within the normal limits of the laboratory reference ranges, the participant may be included in the study only on the condition that the investigator judges the deviations not clinically relevant.
- Signed informed consent for pharmacogenomic testing indicating whether they do or do not wish to participate in the genetic part of the study. NOTE: Participation in the genetic testing component is not mandatory for participation in the study.
- Blood pressure (after the subject is supine for 5 minutes) between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive.
- Are willing to follow the prohibitions and restrictions as specified in the protocol.
Who cannot join
- History of
- seizure disorder or epilepsy, or
- mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or
- severe traumatic brain injury (consisting of one or more of the following: brain contusion; intracranial hematoma; or episode(s) of more than 24 hours duration of unconsciousness or post-traumatic amnesia) within 15 years of screening, or
- severe traumatic brain injury resulting in ongoing sequelae consisting of transient changes in consciousness or symptoms suggestive thereof at any time.
- History of clinically significant pulmonary, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, thromboembolic disease or metabolic disturbances, or any current physical conditions that could interfere with the interpretation of the study results.
Show all 25Show fewer
- History of clinically significant allergies, especially known hypersensitivity or intolerance to opioids, opioid antagonists (e.g., naloxone), benzodiazepines (e.g., diazepam, clonazepam, lorazepam), or any study drug formulation component or any of the excipients, or heparin (should the use of a heparin lock be necessary).
- Positive test for human immunodeficiency virus (HIV 1 and 2), hepatitis B, or hepatitis C.
- History of substance abuse or a positive test for drugs of abuse or alcohol at screening (including on the day before the initial administration of study drug in the first treatment period).
- Blood donation or acute loss of blood (more than 500 mL) during the 3 months before study drug administration or intention to donate blood or blood products during the study or within 1 month after the completion of the study.
- Women who are pregnant, or plan to become pregnant during the study, or who are breast-feeding.
- Participants for whom omeprazole treatment is contraindicated.
- Participants who have used or plan to use the following during the study:
- prescription medication (except for birth control medications and hormone replacement therapy) within 14 days before the first study drug administration
- monoamine-oxidase inhibitors (MAOIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) within 21 days before the first study drug administration
- over-the-counter (OTC) medication, especially nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen) or herbal medication, within 14 days before the first study drug administration
- alcohol, grapefruit, grapefruit juice, or Seville orange products within 48 hours before the first study drug administration.
- Have taken an investigational drug within the 30 days before study administration (Day 1) or within a period of less than 5 times the drug's half-life, whichever is longer.
- Plan to undergo surgery or other procedures during the course of the study.
- Consume alcohol in quantities greater than 3 drinks every day (1 drink is defined as 12 ounces [approximately 360 mL] of beer, 4 ounces [approximately 120 mL] of wine, or 1 ounce [approximately 30 mL] of hard liquor).
- Regularly smoke more than 10 cigarettes/day or the equivalent.
- Unable to refrain from smoking or limit intake of caffeine or methylxanthine-containing foods or beverages (including chocolate) for 2 hours before and for 24 hours after study drug administration in both treatment periods.
- Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug).
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of the investigator or study center, and family members of the employees or the investigator.
- In the opinion of the investigator, are subjects who are not likely to complete the study for whatever reason or who have an inability to communicate meaningfully with the investigator and staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Two-Way Crossover, Drug-Interaction Study to Determine the Effect of Omeprazole on the Pharmacokinetics of an Immediate-Release Capsule of CG5503 in Healthy Subjects
This was a single center, open-label, two-way crossover, drug-drug-interaction study to determine the effect of multiple dosing of omeprazole on 4 consecutive days on the pharmacokinetics of a single dose of an immediate-release capsule of CG5503 (tapentadol) in healthy participants.
- Conditions
- Pharmacokinetic
- Being tested
- Tapentadol IR capsule, Omeprazole capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol IR capsuleDrug
Tapentadol IR capsule containing 93 mg tapentadol hydrochloride.
Omeprazole capsuleDrug
Omeprazole capsule containing 40 mg omeprazole.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol IR | Experimental | A single oral dose of tapentadol IR was administered in a fasted state (Treatment A). Receives: Drug: Tapentadol IR capsule |
| Omeprazole, Tapentadol IR | Experimental | Oral doses of omeprazole were administered once daily in a fasted state on 4 consecutive days (Days -3 to 1), plus 1 capsule of CG5503 IR administered 2 hours after the administration of omeprazole on Day 1 (Treatment B). Receives: Drug: Tapentadol IR capsule; Drug: Omeprazole capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: Cmax of CG5503 base
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the maximum observed serum concentration (Cmax) was based on the CG5503 base concentrations measured in serum samples using a validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) method.
Measured: Pre-dose up to 48 hours post-dose
Pharmacokinetic parameter: AUC0-t of CG5503 base
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the area under the concentration time curve (AUC) from 0 hours to time t (=48 hours) (AUC0-t) was based on the CG5503 base concentrations measured in serum samples.
Measured: Pre-dose up to 48 hours post-dose
Pharmacokinetic parameter: AUC0-inf of CG5503 base
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The AUC from 0 hours to infinity (AUC0-inf) was extrapolated from the AUC from administration to the last measured concentration.
Measured: Pre-dose up to 48 hours post-dose
Secondary outcomes (4)
Pharmacokinetic parameter: Cmax of CG5503-O-glucuronide
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the maximum observed serum concentration (Cmax) was based on the CG5503-O-glucuronide concentrations measured in serum samples using a validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) method.
Measured: Pre-dose up to 48 hours post-dose
Pharmacokinetic parameter: AUC0-t of CG5503-O-glucuronide
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the area under the concentration time curve (AUC) from 0 hours to time t (=48 hours) (AUC0-t) was based on the CG5503-O-glucuronide concentrations measured in serum samples.
Measured: Pre-dose up to 48 hours post-dose
Pharmacokinetic parameter: AUC0-inf of CG5503-O-glucuronide
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The AUC from 0 hours to infinity (AUC0-inf) was extrapolated from the AUC from administration to the last measured concentration.
Measured: Pre-dose up to 48 hours post-dose
Incidence of treatment emergent adverse events
Number of adverse events and number of participants with adverse events.
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start28 Sep 2005
- Primary completion16 Nov 2005
- Study completion16 Nov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies 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
- Participants were randomized to 1 of 2 treatment sequences (AB or BA). There was a washout of at least 7 days between the CG5503 administrations.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Study Director Grünenthal, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979989
- Sponsor's protocol ID
- HP5503/20
- Other IDs
- R331333-PAI-1009
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 10 Jun 2019
- 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 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Way Crossover, Drug-Interaction Study to Determine the Effect of Omeprazole on the Pharmacokinetics of an Immediate-Release Capsule of CG5503 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03979989
- Acronym / sponsor ID
- HP5503/20
- Conditions
- Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- 28 Sep 2005 (actual)
- Primary completion
- 16 Nov 2005 (actual)
- Study completion
- 16 Nov 2005 (actual)
- First posted
- 10 Jun 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.
This was a single center, open-label, two-way crossover, drug-drug-interaction study to determine the effect of multiple dosing of omeprazole on 4 consecutive days on the pharmacokinetics of a single dose of an immediate-release capsule of CG5503 (tapentadol) in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to 1 of 2 treatment sequences (AB or BA). There was a washout of at least 7 days between the CG5503 administrations.
| Arm | Type | Receives |
|---|---|---|
| Tapentadol IR | Experimental | Drug: Tapentadol IR capsuleA single oral dose of tapentadol IR was administered in a fasted state (Treatment A). |
| Omeprazole, Tapentadol IR | Experimental | Drug: Tapentadol IR capsule, Drug: Omeprazole capsuleOral doses of omeprazole were administered once daily in a fasted state on 4 consecutive days (Days -3 to 1), plus 1 capsule of CG5503 IR administered 2 hours after the administration of omeprazole on Day 1 (Treatment B). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Man or woman, between 25 and 55 years of age, inclusive.
- Body mass index between 20 and 28 kg/square meter, inclusive, with a minimum body weight of 50 kg.
- Signed the informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day -1 of Treatment Period 1.
- Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters (serum chemistry, serology, hematology, and urinalysis) performed within 21 days before administration of the first dose of study drug. NOTE: If the results of the chemistry, hematology, or urinalysis testing are not within the normal limits of the laboratory reference ranges, the participant may be included in the study only on the condition that the investigator judges the deviations not clinically relevant.
Key exclusion criteria (25 listed)
- History of
- History of clinically significant pulmonary, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, thromboembolic disease or metabolic disturbances, or any current physical conditions that could interfere with the interpretation of the study results.
- History of clinically significant allergies, especially known hypersensitivity or intolerance to opioids, opioid antagonists (e.g., naloxone), benzodiazepines (e.g., diazepam, clonazepam, lorazepam), or any study drug formulation component or any of the excipients, or heparin (should the use of a heparin lock be necessary).
- Positive test for human immunodeficiency virus (HIV 1 and 2), hepatitis B, or hepatitis C.
- History of substance abuse or a positive test for drugs of abuse or alcohol at screening (including on the day before the initial administration of study drug in the first treatment period).
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 |
|---|---|---|
| Tapentadol IR capsuleTapentadol IR capsule containing 93 mg tapentadol hydrochloride. | Drug | Omeprazole, Tapentadol IR, Tapentadol IR |
| Omeprazole capsuleOmeprazole capsule containing 40 mg omeprazole. | Drug | Omeprazole, Tapentadol IR |
Primary outcome
Pharmacokinetic parameter: Cmax of CG5503 base
Time frame: Pre-dose up to 48 hours post-dose
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the maximum observed serum concentration (Cmax) was based on the CG5503 base concentrations measured in serum samples using a validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) method.
Pharmacokinetic parameter: AUC0-t of CG5503 base
Time frame: Pre-dose up to 48 hours post-dose
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The evaluation of the area under the concentration time curve (AUC) from 0 hours to time t (=48 hours) (AUC0-t) was based on the CG5503 base concentrations measured in serum samples.
Pharmacokinetic parameter: AUC0-inf of CG5503 base
Time frame: Pre-dose up to 48 hours post-dose
14 blood samples for the determination of serum concentrations were taken at pre-dose and up to 48 hours after administration of the CG5503 IR capsule. The AUC from 0 hours to infinity (AUC0-inf) was extrapolated from the AUC from administration to the last measured concentration.
4 secondary outcomes
Pharmacokinetic parameter: Cmax of CG5503-O-glucuronide
Time frame: Pre-dose up to 48 hours post-dose
Pharmacokinetic parameter: AUC0-t of CG5503-O-glucuronide
Time frame: Pre-dose up to 48 hours post-dose
Pharmacokinetic parameter: AUC0-inf of CG5503-O-glucuronide
Time frame: Pre-dose up to 48 hours post-dose
Incidence of treatment emergent adverse events
Time frame: Day 1 to Day 4
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 10 Jun 2019.
- Individual participant dataSharing planned: No
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Healthy Participants
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 Tapentadol IR capsule and Omeprazole capsule in people with Pharmacokinetic, run by Grünenthal GmbH at 1 site in Belgium.
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 25 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Pharmacokinetic parameter: Cmax of CG5503 base (time frame: Pre-dose up to 48 hours post-dose). 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 10 Jun 2019.