Healthy VolunteersPhase 1NCT00756860
A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®)
A Phase 1 study testing AMG 223 and Renagel® (sevelamer hydrochloride) in people with Healthy Volunteers, run by Amgen Research (Munich) GmbH.
Trial summary
The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®. Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia in patients on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AMG 223 and Renagel® (sevelamer hydrochloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2009
- 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
- Healthy non-smoking men and women between the ages of 18 and 45 years, inclusive the time of consent. Healthy is defined as an absence of clinically relevant abnormalities, as identified by a detailed medical history, complete physical examination, vital signs, 12 lead ECG, and clinical laboratory tests at Screening through randomization Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test before study enrollment, and must use a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for an additional 1 month after study completion
- Male participants and/or their partners must use a highly effective form of contraception during sexual intercourse during the study and for an additional 1 month after study completion
- A body mass index (BMI) between 18 and 30 kg/m2, inclusive
- Serum phosphate within normal range
- Willing and able to provide written informed consent
- Willing and able to be confined to the clinical research unit (CRU) as required by the protocol
- Must abstain from any caffeine or alcohol within 72 hours of Day-7 through Day 7 inclusive.
Who cannot join
- Evidence or history of clinically significant hematologic, renal, endocrinologic, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) judged to be relevant by the investigator
- History of bowel obstruction, dysphagia, swallowing disorders, gastrointestinal disorders such as inflammatory bowel disease, constipation, major gastrointestinal surgery, hemorrhoids, or gastric/duodenal ulcers
- Unable or unwilling to swallow numerous capsules/tablets
- Known hypersensitivity to Renagel® or its constituents
- Having an estimated glomerular filtration rate (GFR) < 80 ml/ min (Cockcroft Gault equation)
- Blood donation > 500 mL within 60 days of Screening
Show all 15Show fewer
- History of alcohol abuse (more than 14 alcoholic drinks per week for men and 7 alcoholic drinks per week for women (one drink equals 12 oz beer, 8 oz of wine, or a drink containing one ounce of liquor) or use of illicit drugs within 12 months of Screening
- Positive results for the following tests:
- Urine drug and breath alcohol at Screening or Day -7,
- Serum pregnancy test (females only) at Screening or Day -7,
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HepCAb) at Screening
- Women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study Participation in another clinical trial with any investigational drug or device within 30 days or 5 half lives of the investigational drug (if known), whichever is longer, of study drug administration
- Use of prescription and nonprescription drugs (herbal remedies, vitamins, and nutraceuticals) within 14 days or 5 half-lives, whichever is longer, before Day -7 and during the study (excluding acetaminophen at doses of 2 g/day and hormonal birth control pills)
- Use of prescription and nonprescription drugs that may affect gut motility within 14 days or 5 half-lives, whichever is longer, before Day -7 and during the study
- Subject will not be available for follow-up assessment or concerns for subject's compliance with the protocol procedures
About this study
Official title: A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®) on Phosphate Binding in Healthy Volunteers
The purpose of this study is to determine if subjects on 2g AMG 223 will achieve 60% or greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.
Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia in patients on dialysis.
- Conditions
- Healthy Volunteers
- Being tested
- AMG 223, Renagel® (sevelamer hydrochloride)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 223Drug
2 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7
Renagel® (sevelamer hydrochloride)Drug
2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | 30 subjects will be randomized on Day -1 Receives: Drug: Renagel® (sevelamer hydrochloride) |
| 1 | Experimental | 30 subjects will be randomized on Day -1 Receives: Drug: AMG 223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour urinary phosphorous excretion after multiple doses in healthy volunteers.
Measured: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.
Secondary outcomes (2)
To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour fecal phosphorous excretion after multiple doses in healthy volunteers.
Measured: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.
To assess safety and tolerability of multiple doses of 2g AMG 223 in healthy volunteers.
Measured: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionSep 2009
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen Research (Munich) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756860
- Sponsor's protocol ID
- 20070885
- Status last verified
- May 2012
- First submitted
- 11 Sep 2008
- Last updated
- 4 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Dose Study to Compare the Effects of AMG 223 and Sevelamer HCL (Renagel®) on Phosphate Binding in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00756860
- Acronym / sponsor ID
- 20070885
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amgen Research (Munich) GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Sep 2008 (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 determine if subjects on 2g AMG 223 will achieve 60% or greater reduction in urinary phosphorus from baseline compared to subjects on 2g Renagel®.
Renagel®, Sevelamer HCl is currently the market leader for the treatment of hyperphosphatemia in patients on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Renagel® (sevelamer hydrochloride)30 subjects will be randomized on Day -1 |
| 1 | Experimental | Drug: AMG 22330 subjects will be randomized on Day -1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy non-smoking men and women between the ages of 18 and 45 years, inclusive the time of consent. Healthy is defined as an absence of clinically relevant abnormalities, as identified by a detailed medical history, complete physical examination, vital signs, 12 lead ECG, and clinical laboratory tests at Screening through randomization Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test before study enrollment, and must use a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for an additional 1 month after study completion
- Male participants and/or their partners must use a highly effective form of contraception during sexual intercourse during the study and for an additional 1 month after study completion
- A body mass index (BMI) between 18 and 30 kg/m2, inclusive
- Serum phosphate within normal range
- Willing and able to provide written informed consent
Key exclusion criteria (15 listed)
- Evidence or history of clinically significant hematologic, renal, endocrinologic, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) judged to be relevant by the investigator
- History of bowel obstruction, dysphagia, swallowing disorders, gastrointestinal disorders such as inflammatory bowel disease, constipation, major gastrointestinal surgery, hemorrhoids, or gastric/duodenal ulcers
- Unable or unwilling to swallow numerous capsules/tablets
- Known hypersensitivity to Renagel® or its constituents
- Having an estimated glomerular filtration rate (GFR) < 80 ml/ min (Cockcroft Gault equation)
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 2232 g AMG 223 (4 x 500 mg capsules ) TID on Days 1 through 7 | Drug | 1 |
| Renagel® (sevelamer hydrochloride)2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7 | Drug | 2 |
Primary outcome
To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour urinary phosphorous excretion after multiple doses in healthy volunteers.
Time frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.
2 secondary outcomes
To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour fecal phosphorous excretion after multiple doses in healthy volunteers.
Time frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.
To assess safety and tolerability of multiple doses of 2g AMG 223 in healthy volunteers.
Time frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.
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 Jun 2012.
- 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 223 and Renagel® (sevelamer hydrochloride) in people with Healthy Volunteers, run by Amgen Research (Munich) GmbH.
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 7 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 4 Jun 2012. 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?
To compare the effects of 2g AMG 223 and 2g Renagel® on 24 hour urinary phosphorous excretion after multiple doses in healthy volunteers. (time frame: Including the 28-day Screening period, the 15-day residency period, and the follow-up on Day 15 (one week after discharge from the clinical research unit), the maximum subject participation is approximately 50 days.). 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 Jun 2012.