Healthy VolunteersPhase 1NCT02957474
A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects
A Phase 1 study testing GED-0301 and Omeprazole in people with Healthy Volunteers, run by Celgene at 1 site in United Kingdom.
Trial summary
This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co administration with omeprazole, a proton pump inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GED-0301 and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Dec 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 65 years of age the time of signing the ICF.
- Subject must understand and voluntarily sign an ICF prior to any study related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
- Female subjects NOT of childbearing potential must:
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- Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle stimulating hormone [FSH] level of > 40 IU/L at screening).
- Females of childbearing potential (FCBP) must have a negative pregnancy test at the Screening and Baseline Visits. While receiving investigational product (IP) and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.
- OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- Male subjects must:
- Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 28 days after the last dose of IP, even if he has undergone a successful vasectomy.
- Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.
- Subject vitals are as follows:
- Tympanic body temperature: 35.0 - 37.5°C.
- Supine blood pressure (BP) after at least 5 minutes supine rest:
- Systolic BP: 90 - 140 mmHg ii. Diastolic BP: 40 - 90 mmHg c. Supine heart rate (after at least 5 minutes of rest): 40 - 90 beats per minute d. Postural drop (standing BP taken after no more than 1 minute standing) of ≤20 mmHG (systolic) or ≤10 mmHg (diastolic) associated with clinically relevant symptoms.
- Subject has a normal or clinically acceptable 12 lead ECG at screening. In addition:
- If male, subject has a QTcF value ≤ 430 msec at screening.
- If female, subject has a QTcF value ≤ 450 msec at screening.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subjects who have:
- previously been exposed to GED 0301; or b. been exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).
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- Subject has used any prescription drugs or over-the-counter medication (including multi-vitamins) in the 14 days prior to the planned admission day.
- 1. Subject has consumed herbal remedies or dietary supplements containing St. John's Wort, in the three weeks before the planned admission day.
- 6. Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
- 7. Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- 8. Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
- 9. Subject has a history or clinical evidence of substance and/or alcohol abuse within the 12 months before screening. Alcohol abuse is defined as regular weekly intake of more than 14 units (using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx).
- 10. Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- 11. Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
- 12. Subject is part of the clinical staff personnel or a family member of the clinical site staff.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology, Ltd.
Croydon, Surrey, CR7 7YE
About this study
Official title: A Phase 1, Open Label, Single Center, Randomized, Six-Sequence, Crossover Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects
This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co administration with omeprazole, a proton pump inhibitor.
The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow up phone call five days (± 1 day) after discharge.
Read the detailed description
Subjects will be consented and screened within 21 days of dosing. They will undergo routine screening procedures including physical examinations (PE), 12 lead electrocardiograms (ECGs), vital sign measurements, clinical laboratory safety tests (clinical chemistry, haematology, urinalysis), pregnancy tests for females, and serology/drug/alcohol screens.
Eligible subjects will return to the clinic site on Day -1 for baseline safety assessments. After an overnight fast of at least 10 hours, subjects will be assigned randomly to one of six treatment sequences which will determine fasting status and the order in which treatments will be administered.
Subjects in the fasted arm will receive either a single 160 mg tablet of GED 0301 or four 40 mg tablets of GED 0301, with approximately 240 mL of room temperature, non-carbonated water.
Subjects in the fed arm will be required to fast overnight for at least 10 hours. On the morning of dosing, these subjects will be served a high-fat meal. The meal should be entirely consumed within 20 minutes of being served. Dosing of a single160 mg tablet of GED 0301 will occur within 30 minutes (± 5 minutes) after the start of the meal.
During the fourth period, subjects will receive once daily oral doses of 40 mg omeprazole for 6 days (Days 10 through 16). Subjects will fast on the evening of the fourth day for at least 10 hours prior to receiving the last treatment, which is a single dose of 160 mg GED 0301 together with one 40 mg oral dose of omeprazole (Day 15). On Day 16, subjects will take the last dose of omeprazole.
Serial blood sampling for the determination of GED 0301 levels in plasma will be performed during each period for 48 hours post dose.
Subjects will be domiciled at the clinic site from Day 1 of Period 1 until Day 17. All subjects will be discharged from the clinic site on Day 17 when all required safety and PK procedures have been completed.
A follow up phone call will occur five days (± 1 day) after discharge from the clinic center.
The study will be conducted in compliance with Good Clinical Practice (GCP), as described in International Conference on Harmonisation (ICH) Guideline E6 and in accordance with the general ethical principles outlined in the Declaration of Helsinki. The study will receive approval from an EC prior to commencement. The Investigator will conduct all aspects of this study in accordance with applicable national, state, and local laws of the pertinent regulatory authorities.
- Conditions
- Healthy Volunteers
- Being tested
- GED-0301, Omeprazole
- Keywords
- Healthy Volunteers, Pharmacokinetics, Food Effect, Proton Pump, GED-0301, Mongersen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GED-0301Drug
Also called Mongersen
OmeprazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A = single oral dose GED 0301, fasted | Experimental | Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast Receives: Drug: GED-0301 |
| Treatment B = single oral dose GED 0301, fed | Experimental | Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast, and within 30 minutes of completely consuming a high fat meal. Receives: Drug: GED-0301 |
| Treatment C = single oral dose GED 0301 fasted | Experimental | Subjects will receive an oral dose of 160 mg of GED-0301 given as 4 tablets of 40 mg, after a 10 hour overnight fast Receives: Drug: GED-0301 |
| Treatment D = oral omeprazole and GED-0301 | Experimental | Subjects will receive one oral dose of 40 mg omeprazole once a day for 6 days. On the 5th day, a single oral 160 mg dose of GED-0301 will be given together with omeprazole. Receives: Drug: GED-0301; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum observed concentration in plasma
Measured: Up to Day 17
Pharmacokinetics -AUC0-∞
Estimation of AUC from time zero extrapolated to infinity
Measured: Up to Day 17
Secondary outcomes (1)
Adverse Event (AE)
Number of participants with adverse events
Measured: Up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palminsano, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957474
- Sponsor's protocol ID
- GED-0301-CP-001
- Status last verified
- Jan 2017
- First submitted
- 3 Nov 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single Center, Randomized, Six-Sequence, Crossover Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02957474
- Acronym / sponsor ID
- GED-0301-CP-001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Pharmacokinetics, Food Effect, Proton Pump, GED-0301, Mongersen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co administration with omeprazole, a proton pump inhibitor.
The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow up phone call five days (± 1 day) after discharge.
Detailed description
Subjects will be consented and screened within 21 days of dosing. They will undergo routine screening procedures including physical examinations (PE), 12 lead electrocardiograms (ECGs), vital sign measurements, clinical laboratory safety tests (clinical chemistry, haematology, urinalysis), pregnancy tests for females, and serology/drug/alcohol screens.
Eligible subjects will return to the clinic site on Day -1 for baseline safety assessments. After an overnight fast of at least 10 hours, subjects will be assigned randomly to one of six treatment sequences which will determine fasting status and the order in which treatments will be administered.
Subjects in the fasted arm will receive either a single 160 mg tablet of GED 0301 or four 40 mg tablets of GED 0301, with approximately 240 mL of room temperature, non-carbonated water.
Subjects in the fed arm will be required to fast overnight for at least 10 hours. On the morning of dosing, these subjects will be served a high-fat meal. The meal should be entirely consumed within 20 minutes of being served. Dosing of a single160 mg tablet of GED 0301 will occur within 30 minutes (± 5 minutes) after the start of the meal.
During the fourth period, subjects will receive once daily oral doses of 40 mg omeprazole for 6 days (Days 10 through 16). Subjects will fast on the evening of the fourth day for at least 10 hours prior to receiving the last treatment, which is a single dose of 160 mg GED 0301 together with one 40 mg oral dose of omeprazole (Day 15). On Day 16, subjects will take the last dose of omeprazole.
Serial blood sampling for the determination of GED 0301 levels in plasma will be performed during each period for 48 hours post dose.
Subjects will be domiciled at the clinic site from Day 1 of Period 1 until Day 17. All subjects will be discharged from the clinic site on Day 17 when all required safety and PK procedures have been completed.
A follow up phone call will occur five days (± 1 day) after discharge from the clinic center.
The study will be conducted in compliance with Good Clinical Practice (GCP), as described in International Conference on Harmonisation (ICH) Guideline E6 and in accordance with the general ethical principles outlined in the Declaration of Helsinki. The study will receive approval from an EC prior to commencement. The Investigator will conduct all aspects of this study in accordance with applicable national, state, and local laws of the pertinent regulatory authorities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A = single oral dose GED 0301, fasted | Experimental | Drug: GED-0301Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast |
| Treatment B = single oral dose GED 0301, fed | Experimental | Drug: GED-0301Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast, and within 30 minutes of completely consuming a high fat meal. |
| Treatment C = single oral dose GED 0301 fasted | Experimental | Drug: GED-0301Subjects will receive an oral dose of 160 mg of GED-0301 given as 4 tablets of 40 mg, after a 10 hour overnight fast |
| Treatment D = oral omeprazole and GED-0301 | Experimental | Drug: GED-0301, Drug: OmeprazoleSubjects will receive one oral dose of 40 mg omeprazole once a day for 6 days. On the 5th day, a single oral 160 mg dose of GED-0301 will be given together with omeprazole. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 65 years of age the time of signing the ICF.
- Subject must understand and voluntarily sign an ICF prior to any study related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
- Female subjects NOT of childbearing potential must:
Key exclusion criteria (15 listed)
- Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subjects who have:
- Subject has used any prescription drugs or over-the-counter medication (including multi-vitamins) in the 14 days prior to the planned admission day.
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 |
|---|---|---|
| GED-0301Also: Mongersen | Drug | Treatment A = single oral dose GED 0301, fasted, Treatment B = single oral dose GED 0301, fed, Treatment C = single oral dose GED 0301 fasted, Treatment D = oral omeprazole and GED-0301 |
| Omeprazole | Drug | Treatment D = oral omeprazole and GED-0301 |
Primary outcome
Pharmacokinetics - Cmax
Time frame: Up to Day 17
Maximum observed concentration in plasma
Pharmacokinetics -AUC0-∞
Time frame: Up to Day 17
Estimation of AUC from time zero extrapolated to infinity
1 secondary outcome
Adverse Event (AE)
Time frame: Up to Day 22
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 12 Jan 2017.
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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.
Maria Palminsano, MD study director
Celgene Corporation
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 GED-0301 and Omeprazole in people with Healthy Volunteers, run by Celgene at 1 site in United Kingdom.
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 21 inclusion and 15 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Pharmacokinetics - Cmax (time frame: Up to Day 17). The study lists 2 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 12 Jan 2017.