Healthy VolunteersPhase 1NCT01124279
Single-dose, Pharmacokinetics of AMG 853 in Healthy Adult Subjects
A Phase 1 study testing AMG 853 in people with Healthy Volunteers, run by Amgen.
Trial summary
To determine the bioavailability and the effect of food on the pharmacokinetics under fasted and fed conditions Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AMG 853
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-nicotine or tobacco using, healthy male and/or female subjects between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician
- Females must be of non-reproductive potential (ie, postmenopausal by history - no menses for 1 year - and FSH consistent with postmenopausal status per laboratory ranges; or history of hysterectomy; or history of bilateral tubal ligation; or history of bilateral oophorectomy).
- Physical examination, clinical laboratory test values and ECGs are clinically acceptable to the investigator and Amgen.
- Males must agree to use highly effective methods of birth control for the duration of the study and continuing for 12 weeks after the last dose of AMG 853. Highly effective methods of birth control (i.e., those with a failure rate of less than 1% per year) include sexual abstinence, vasectomy or a condom supplemented with the use of a spermicide, where available, in combination with one of the following methods used by the female partner: in regions where spermicide is available, diaphragm or cervical/vault caps supplemented with spermicide, hormonal birth control (implants, injectables, or combined oral contraceptives), intrauterine devices (IUDs).
- Male subjects whose partners become pregnant during the study will not receive subsequent scheduled doses, must practice sexual abstinence or use a condom for two weeks following the last dose, and will be followed for safety through end of study. The pregnant partner information will be reported to Amgen as per the Pregnancy Notification Worksheet.
- Body mass index between 18 and 30 kg/m2, inclusive.
Who cannot join
- History or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Creatinine clearance within the screening period of less than 80 mL/min as calculated by the Cockcroft-Gault method.
- History suggestive of esophageal, gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy.
- Any positive test for cotinine (tobacco use) on the day before dosing of each treatment period (day -1, 7, 14 and 21). A positive cotinine level is defined as any level exceeding the upper limit of normal per local laboratory reference ranges.
- Known substance abuse (eg, alcohol, licit or illicit drugs) within 1 year of dosing.
- Any positive test for drugs and or alcohol use on the day before dosing of each treatment period (day -1, 7, 14 and 21). Alcohol should not be consumed within 48 hours of day -1 and throughout the study.
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- Females who are lactating/breastfeeding.
- Males with pregnant partners.
- Subjects who require specialized diets or have dietary restrictions that would prevent them from complying with the study requirements.
- Inability or unwillingness to swallow tablets.
- Unwilling to consume a standardized high-fat breakfast (approximately 800 to 1000 calories) consisting of approximately 33 g protein, 58 g carbohydrate, and 75 g fat, respectively (e.g. 2 eggs fried in butter, 2 strips of bacon, 2 slices of toast with butter, 4 ounces of hash-brown potatoes, and 8 ounces of whole milk).
- Subjects who are lactose intolerant
- A history of malignancy of any type, other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years before the day of dosing.
- Donated greater than 500 mL of blood or blood products within 60 days of dosing.
- Receiving or has received any investigational drug (or using or has used an investigational device) within the 30 days before receiving the first dose of study medication, or at least 5 elimination half-lives (whichever is longer).
- Subjects who were previously exposed to AMG 853.
- Use of any over-the-counter or prescription medications (specifically including, but not limited to, antacids, H2- blockers, and proton pump inhibitors, aspirin or other non-steroidal anti-inflammatory drugs [NSAIDS]) within 30days of dosing. Acetaminophen (up to 2 g per day) for analgesia and hormone replacement therapy (eg, estrogen) will be allowed.
- Use of any known inhibitors of CYP3A4/P-gp such as ketoconazole, itraconazole, HIV protease inhibitors, nefazadone, cyclosporine, erythromycin, clindamycin, tetracycline, and clarithromycin within 14 days or 5 half lives, which ever is longer; or grapefruit juice or grapefruit containing products within 7 days prior to investigational product administration.
- Use of any known CYP inducers such as rifampin, corticosteroids, or anticonvulsants within 30 days or 5 half-lives, which ever is longer, before investigational product administration.
- Use of any herbal medicine (eg, St. John's wort) within 30 days before investigational product administration. All herbal medicines, vitamins, and supplements consumed by the subject within 30 days prior to the first dose of investigational product and continued use, if appropriate, will be reviewed by the Principal Investigator and the Amgen Medical Monitor.
- History of hypersensitivity or allergic reaction to sulfonamide drugs.
- Positive for HIV antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- Known history of Gilbert's syndrome.
- Any other condition that might reduce the chance of obtaining data (eg, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent.
About this study
Official title: A Phase I, Randomized, Open-Label, Single-Dose, 2-Part, 4-Treatment, 4-Way Crossover Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics of Various AMG 853 Formulations When Administered Under Fasted and Fed Conditions
To determine the bioavailability and the effect of food on the pharmacokinetics under fasted and fed conditions
- Conditions
- Healthy Volunteers
- Being tested
- AMG 853
- Keywords
- Amgen, Healthy, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 853Drug
Single dose administration of AMG 853 in tablet form to healthy adult subjects
| Study group | Role | What they receive |
|---|---|---|
| AMG 853 | Experimental | Not described Receives: Drug: AMG 853 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Measured: throughout study duration
Secondary outcomes (1)
Treatment-emergent adverse events, safety and laboratory assessments
Measured: throughout study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionOct 2010
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 AmgenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124279
- Sponsor's protocol ID
- 20090226
- Status last verified
- Jan 2011
- First submitted
- 13 May 2010
- Last updated
- 7 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-Label, Single-Dose, 2-Part, 4-Treatment, 4-Way Crossover Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics of Various AMG 853 Formulations When Administered Under Fasted and Fed Conditions
- ClinicalTrials.gov ID
- NCT01124279
- Acronym / sponsor ID
- 20090226
- Conditions
- Healthy Volunteers
- Keywords
- Amgen, Healthy, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 May 2010 (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.
To determine the bioavailability and the effect of food on the pharmacokinetics under fasted and fed conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMG 853 | Experimental | Drug: AMG 853 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-nicotine or tobacco using, healthy male and/or female subjects between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician
- Females must be of non-reproductive potential (ie, postmenopausal by history - no menses for 1 year - and FSH consistent with postmenopausal status per laboratory ranges; or history of hysterectomy; or history of bilateral tubal ligation; or history of bilateral oophorectomy).
- Physical examination, clinical laboratory test values and ECGs are clinically acceptable to the investigator and Amgen.
- Males must agree to use highly effective methods of birth control for the duration of the study and continuing for 12 weeks after the last dose of AMG 853. Highly effective methods of birth control (i.e., those with a failure rate of less than 1% per year) include sexual abstinence, vasectomy or a condom supplemented with the use of a spermicide, where available, in combination with one of the following methods used by the female partner: in regions where spermicide is available, diaphragm or cervical/vault caps supplemented with spermicide, hormonal birth control (implants, injectables, or combined oral contraceptives), intrauterine devices (IUDs).
- Male subjects whose partners become pregnant during the study will not receive subsequent scheduled doses, must practice sexual abstinence or use a condom for two weeks following the last dose, and will be followed for safety through end of study. The pregnant partner information will be reported to Amgen as per the Pregnancy Notification Worksheet.
Key exclusion criteria (24 listed)
- History or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Creatinine clearance within the screening period of less than 80 mL/min as calculated by the Cockcroft-Gault method.
- History suggestive of esophageal, gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy.
- Any positive test for cotinine (tobacco use) on the day before dosing of each treatment period (day -1, 7, 14 and 21). A positive cotinine level is defined as any level exceeding the upper limit of normal per local laboratory reference ranges.
- Known substance abuse (eg, alcohol, licit or illicit drugs) within 1 year of dosing.
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 |
|---|---|---|
| AMG 853Single dose administration of AMG 853 in tablet form to healthy adult subjects | Drug | AMG 853 |
Primary outcome
Pharmacokinetic parameters
Time frame: throughout study duration
1 secondary outcome
Treatment-emergent adverse events, safety and laboratory assessments
Time frame: throughout study duration
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 7 Jan 2011.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 853 in people with Healthy Volunteers, run by Amgen.
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 6 inclusion and 24 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 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 parameters (time frame: throughout study duration). 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 7 Jan 2011.