AsthmaPhase 1NCT01137565
Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With Asthma
A Phase 1 study testing AMG 853 in people with Asthma, run by Amgen.
Trial summary
The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- AMG 853
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jan 2011
- 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and/or female subjects ≥12 to < 18 years of age (for Cohorts 1, 2, and 3 as indicated in the study design).
- Male and/or non-reproductive female subjects between 18 and 50 years of age, inclusive (for cohort 4).
- Females of non-reproductive potential must have documented medical history (ie, postmenopausal by history - no menses for 1 year - and follicle-stimulating hormone value (FSH) consistent with postmenopausal status per laboratory ranges; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- Females of child-bearing potential and females who cannot document non-reproductive potential must agree to use highly effective methods of birth control for the duration of the study and for 2 weeks after study drug administration. Males whose partners are of child bearing potential must agree to use highly effective methods of birth control for the duration of the study and continuing for 12 weeks after study drug administration. Highly effective methods of birth control (i.e., those with a failure rate of less than 1% per year) include sexual abstinence (males, females), vasectomy or a condom supplemented with the use of a spermicide (males) and occlusive cap (diaphragm or cervical/vault caps), hormonal birth control, or intrauterine device (IUD) used by the female partner.
- Male subjects whose partners become pregnant during the study must practice sexual abstinence or use a condom with spermicide for two weeks following study drug administration to ensure the unborn child is not potentially exposed to AMG 853 via semen. The pregnant partner information will be reported to Amgen per the Pregnancy Notification Worksheet.
- Intermittent or mild to moderate persistent asthma for the past 3 months (as defined by the 2004 Global Initiative for Asthma [GINA] guidelines).
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- On a stable pharmacologic regimen for the treatment of asthma for at least 3 months prior to study enrollment and does not anticipate any change to the regimen during the course of the study.
- Forced Expiry Volume in 1 second (FEV1) at screening visit ≥ 70% of predicted normal value (without aid of bronchodilator).
- FEV1 reversibility greater than or equal to 12% from baseline within 30 minutes of inhaled (up to 400 μg) or nebulized (up to 5 mg) albuterol at the office screening visit. Subjects unable to demonstrate reversibility during screening, must provide the most recent evidence of documented reversibility to the Amgen Medical Monitor and the principal investigator for review.
- Clinically acceptable physical examination, electrocardiogram (ECG), and clinical laboratory test values for the population tested. Any abnormal clinical laboratory results and/or ECG values must be discussed with the Sponsor.
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.
- Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.
- Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.
- Use of oral corticosteroids within 3 months prior to study enrollment.
- Evidence of recent (within 2 weeks of study enrollment) or current signs or symptoms of an upper respiratory infection (eg, viral, bacterial).
- Known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or untreated exposure to a patient with active tuberculosis.
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- History of autoimmune disorder (eg, rheumatoid arthritis, systemic lupus).
- Creatinine clearance within the screening period of less than 80 mL/min as calculated by the Cockcroft-Gault method.
- History of clinically significant cardiovascular, renal, hepatic or respiratory disease other than asthma.
- 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 (excluding uncomplicated appendectomy).
- Any positive test for cotinine (tobacco use) on the day before dosing. A positive cotinine level is defined as any level exceeding the upper limit of normal as per local laboratory reference ranges.
- Known substance abuse (eg, alcohol, licit or illicit drugs) within 1 year of dosing as defined by Diagnostic and Statistical Manual version 4, text revsion (DSM-IV-TR) criteria.
- Any positive test for drugs and or alcohol use on the day before dosing (day -1). For subjects of legal drinking age, alcohol should not be consumed within 48 hours of day -1 and throughout the study. Alcohol use is not permitted for subjects below the legal drinking age.
- Positive pregnancy test at screening or day -1.
- Females who are lactating or breastfeeding.
- with pregnant partners.
- Inability or unwillingness to swallow tablets.
- 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.
- Subjects who have received any investigational drug (or have 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 prescription (eg, angiotensin inhibitors) or non-prescription [eg, non-steroidal anti-inflammatory drugs (NSAIDS)] medications including asthma medications (eg, inhaled cromolyn, inhaled ipratropium, inhaled tiotropium, theophylline) within 7 days of study start with the exception of inhaled corticosteroid therapy (≤ 660 μg/day fluticasone or ≤ 480 μg/day beclomethasone, or equivalent), inhaled short-acting and long-acting β-2 agonists, and montelukast.
- 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 NSAIDS within 28 days 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, whichever 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, oral corticosteroids, or anticonvulsants within 30 days or 5 half-lives, whichever is longer, before investigational product administration.
- All herbal medicines (eg, St. John's Wort), 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 human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- Known history of Gilbert's syndrome.
- Unwilling or unable to return to the research facility for follow-up assessments as required per protocol.
- 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 Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 853 in Adolescent (≥ 12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma
The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
- Conditions
- Asthma
- Being tested
- AMG 853, Placebo
- Keywords
- Amgen, Adolescent, Safety
- Medical subject headings
- Asthma
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 or placebo in tablet form to adolescent and adult subjects with asthma
PlaceboDrug
Placebo to AMG 853
| Study group | Role | What they receive |
|---|---|---|
| AMG 853 | Experimental | Not described Receives: Drug: AMG 853 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
Measured: Throughout the study duration
Secondary outcomes (1)
Pharmacokinetic parameters (including Cmax and AUC) for a single dose administration of AMG 853 in adolescent and adult subjects
Measured: Throughout study duration (at predose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 168 hours after dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137565
- Sponsor's protocol ID
- 20090223
- Status last verified
- Mar 2014
- First submitted
- 22 Apr 2010
- Last updated
- 4 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 853 in Adolescent (≥ 12 to <18 Years) and Adult Subjects With Intermittent or Mild to Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01137565
- Acronym / sponsor ID
- 20090223
- Conditions
- Asthma
- Keywords
- Amgen, Adolescent, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Jun 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.
The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 853 | Experimental | Drug: AMG 853 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Male and/or female subjects ≥12 to < 18 years of age (for Cohorts 1, 2, and 3 as indicated in the study design).
- Male and/or non-reproductive female subjects between 18 and 50 years of age, inclusive (for cohort 4).
- Females of non-reproductive potential must have documented medical history (ie, postmenopausal by history - no menses for 1 year - and follicle-stimulating hormone value (FSH) consistent with postmenopausal status per laboratory ranges; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- Females of child-bearing potential and females who cannot document non-reproductive potential must agree to use highly effective methods of birth control for the duration of the study and for 2 weeks after study drug administration. Males whose partners are of child bearing potential must agree to use highly effective methods of birth control for the duration of the study and continuing for 12 weeks after study drug administration. Highly effective methods of birth control (i.e., those with a failure rate of less than 1% per year) include sexual abstinence (males, females), vasectomy or a condom supplemented with the use of a spermicide (males) and occlusive cap (diaphragm or cervical/vault caps), hormonal birth control, or intrauterine device (IUD) used by the female partner.
- Male subjects whose partners become pregnant during the study must practice sexual abstinence or use a condom with spermicide for two weeks following study drug administration to ensure the unborn child is not potentially exposed to AMG 853 via semen. The pregnant partner information will be reported to Amgen per the Pregnancy Notification Worksheet.
Key exclusion criteria (31 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.
- Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.
- Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.
- Use of oral corticosteroids within 3 months prior to study enrollment.
- Evidence of recent (within 2 weeks of study enrollment) or current signs or symptoms of an upper respiratory infection (eg, viral, bacterial).
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 or placebo in tablet form to adolescent and adult subjects with asthma | Drug | AMG 853 |
| PlaceboPlacebo to AMG 853 | Drug | Placebo |
Primary outcome
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability
Time frame: Throughout the study duration
1 secondary outcome
Pharmacokinetic parameters (including Cmax and AUC) for a single dose administration of AMG 853 in adolescent and adult subjects
Time frame: Throughout study duration (at predose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96 and 168 hours after 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 4 Mar 2014.
- 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 Asthma, 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 10 inclusion and 31 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 4 Mar 2014. 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. Some participants in this study may receive a placebo. 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?
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability (time frame: Throughout the 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 4 Mar 2014.