A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults
NCT ID: NCT01601600
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2012-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
BYM338 Placebo
BYM338
BYM338 active drug
BYM338
BYM338
Interventions
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BYM338
BYM338
Placebo
BYM338 Placebo
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent must be obtained before any laboratory or physical assessment is performed to establish eligibility. Answering initial questions for qualification, whether in person or over the phone does not require written consent.
3. At the onsite screening, candidates should have gait speed measured over 4 meters of \<1.0 m/s but ≥0.6 m/s.
4. Appendicular skeletal muscle index (skeletal muscle in kg/ height in m2) by DXA ≤ 7.25 kg/m2 for men and ≤ 5.67 kg/m2 for women to be assessed during screening if the gait speed criterion in #3 is met.
5. At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position followed by assessment in standing within three (3) minutes of changing position. Investigators can be guided by the following ranges for the supine measurement and position change:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 80-160 mm Hg and a reduction of \>20mmHg
* diastolic blood pressure, 50-90 mm Hg and a reduction of \>10mmHg
* pulse rate, 50 - 100 bpm
6. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2, inclusive. (See Appendix 4) of this protocol for BMI ranges.
7. Be able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion Criteria
2. History of hypersensitivity to antibodies.
3. A history of clinically significant ECG abnormalities, which, in the opinion of the investigator, may indicate active cardiac disease.
4. History of malignancy of any organ system (other than localized nonmelanomatous cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
5. Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, COPD, chronic kidney disease (estimated GFR \< 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus.
6. Diseases known to cause malabsorption of protein or energy, including inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency, etc.
7. Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, or serum bilirubin (except Gilbert's
Disease). The Investigator should be guided by the following criteria:
* Any single transaminase listed above may not exceed 3x upper limit of normal (ULN).
* If the total bilirubin concentration is increased above 1.5 x ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1.6 mg/dL (27 μmol/L). 8. Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, etc. 9. Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation. 10. Plasma donation (\> 250 mL) within 14 days prior to first dosing. 11. Hemoglobin concentration below 11.0 g/dL at screening. 12. Significant illness within two (2) weeks prior to initial dosing. 13. Patients with known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit administration of MRI assessments. 14. Patient smokes more than one cigarette, pipe or cigar a month
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Hot Springs, Arkansas, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Brighton, Massachusetts, United States
Countries
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Related Links
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Results for CBYM338X2201 from the Novartis Clinical Trials Results Website
Other Identifiers
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CBYM338X2201
Identifier Type: -
Identifier Source: org_study_id