Lochol Study Synopsis Brochure And Assignment Instructions

SYNOPSIS

Title of Study:

A randomized, double-blind, placebo-controlled, multiple-dose safety and tolerance study of LOCHOL in healthy male volunteers

Investigative Site:

CRO

Anticipated Study Duration:

Anticipated Start Date for Study Enrollment: January, 2009
Anticipated Completion Date for Study Enrollment: October, 2009
Anticipated Date of Last Study Visit: November, 2009

Objective:

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of 250 mg Lochol when administered once daily for 2 weeks

Methodology:

Subjects will have a screening visit within 6 weeks prior to the Baseline visit. The subjects will be admitted to the clinical research unit on Day -7 to begin the NCEP Adults Treatment Panel III (ATPIII) Therapeutic Lifestyles Changes (TLC) Diet stabilization. The diet will be maintained through Day 17. Subjects will receive single oral doses of placebo or 250 mg LOCHOL once daily for 2 weeks beginning on Day 1. The subjects will be confined in the clinic from Day -7 to Day 17 for careful monitoring of potential study drug effects as well as to ensure maintained compliance with the NCEP Adults Treatment Panel III Therapeutic Lifestyles Changes Diet. Subjects will be released from the clinic on Day 17. Subjects will be monitored for routine safety labs, ECGs, vital signs, physical exams, and adverse events.

Number of Subjects:

24 subjects/1 cohort (16 active/8 placebo)

Diagnosis and Main Criteria for Inclusion:

Healthy males between ages 18 and 65 years with LDL values >100 mg/dL

Product Information:

Lochol is an ester of a well-known cholesterol-reducing agent that has been associated with an increase in LFTs, myalgia, and, rarely, rhabdomyolysis. Tell patients to promptly report muscle pain, tenderness, or weakness. Discontinue drug if myopathy is suspected, if creatine phosphokinase (CPK) levels rise markedly, or if the patient has risk factors for rhabdomyolysis.

Lower starting doses should be considered when administered concomitantly with cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, ritonavir/saquinavir, ritonavir/lopinavir, immunosuppressive drugs, azole antifungals, or niacin; additionally, physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating dose of either drug.

Comparator Product:

Placebo for Lochol

Assessments:

Adverse events
Clinical laboratory measurements
Pharmacokinetic values
ECGs
Physical exams

Primary Efficacy Measurements:

None

Secondary Efficacy Measurements:

None

Safety and Tolerance:

• Routine monitoring of adverse events (AEs)
• Clinical laboratory specimens for testing of standard safety panels for chemistry, hematology, and urinalysis
• Vital signs
• Physical exam results
• ECGs

Pharmacokinetics:

Serial plasma specimens will be taken for study drug-level determinations.

Pharmacodynamics:

Measurement of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Lp(a), Apolipoprotein-A , and Apolipoprotein-B

Statistical Methods:

Statistical Analysis Plan:

  • Pharmacodynamic evaluation:

Total Cholesterol

HDL Cholesterol
LDL Cholesterol (direct measurement)
Triglycerides
Lp(a)
Apolipoprotein-A
Apolipoprotein-B

All pharmacodynamic parameters will be listed and summarized by treatment group. Differences at end of therapy relative to baseline will be examined by treatment group. The mean of three lipid values measured on 3 consecutive days will be used for Baseline (Days -2, -1, and 1) and End of Therapy (Days 13, 14 and 15) values in order to decrease the intrasubject variability of the lipid measurements when comparing treatment groups.

  • Safety evaluation:

All subjects who receive study medication and have a subsequent safety evaluation will be included in the safety analyses.

All adverse events reported during the study will be listed, documenting course, severity, and outcome. Adverse events will be coded to MedDRA terms.

Adverse event reports summarized by treatment group will give the number of subjects who experienced an adverse event, the maximum severity, and body system.

Laboratory parameters, vital signs, and physical exam results will be summarized by treatment group with the statistics of n, mean, standard deviation, median and range or frequencies and percentages, as appropriate, for baseline, on therapy, and posttherapy values.

All ECG data measured during the study will be listed and summarized by treatment group.

  • Pharmacokinetic evaluation:

Pharmacokinetic parameters (e.g., Cmax, Tmax, t1/2, AUC(0-24), AUC(0-t), AUC(0-inf), Kel, Ae%, CLr,, and CLt ) will be estimated for each treatment group using noncompartmental methods. Pharmacokinetic parameters will be summarized by treatment group using descriptive statistics, as appropriate.

Assignment Instructions

Risks and Benefits in Clinical Trials

Most positions on a clinical research team require that you analyze the protocol design and the protocol procedures’ implications. One aspect of protocol design is understanding the problems that could arise during the trial. This Application Assignment provides you with an example of an abbreviated protocol for a drug, Lochol, from which you can extrapolate potential problems and benefits that could arise from the study outcome.
Thoroughly review the Lochol Study Synopsis Brochure. Based on information in the brochure, consider the drug’s risks and benefits.
Write a 1-page paper that outlines the study’s potential risks and benefits. Be sure to include at least two examples of benefits and two examples of risks. Then, based on these risks and benefits, justify whether you would continue the drug development process by following up the 2-week study (as listed in the Lochol Study Brochure) with a 4-week study at 250 mg/day.
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