Healthy Combine Study (NCT03136705) | Clinical Trial Compass
CompletedPhase 1
Healthy Combine Study
United States39 participantsStarted 2016-02-03
Plain-language summary
STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration: 12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives: Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria: Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration of administration: 2 weeks (length of time study participants are enrolled in study) Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis using mixed linear models
Who can participate
Age range18 Years – 60 Years
SexALL
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INCLUSION CRITERIA
Healthy volunteers
Age ≥ 18 years, at the time of screening
Normal renal function at screening, as defined by
* eGFR \> 60
* no albuminuria
* normal urinalysis
* normotensive, defined as blood pressure \<140/85mmHg
* no known history of CKD
Adequate organ and marrow function at screening as defined below:
* HCT ≥ 30%
* platelets ≥ 125,000/mm3
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit
* 25-hydroxyvitamin D ≥ 10mg/dL
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Ability to understand and the willingness to sign a written informed consent.
EXCLUSION CRITERIA:
History of allergic reaction to nicotinamide, niacin (excluding flushing), and/or multivitamin preparations
Liver disease, defined as known cirrhosis by imaging or physician diagnosis.
* Documented alcohol use \> 14 drinks/week
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or alkaline phosphatase concentrations \> 2 times the upper limit of the local laboratory reference range and/or total bilirubin concentration not within institutional limits.
Creatine kinase (CK) concentrations \> 2 times the upper limit of the local laboratory reference range at screening
Major hemorrhagic event within the past…