Thorough QT Study # 2 |
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IDENTIFICATION : E-HOL-12-0140-008 |
Study Design: This is a single-center, single-dose, randomized, double-blind, double-dummy, placebo-controlled, active-comparator, four-way crossover study. Each subject received a single dose of each of treatment (i.e., A, B, C, and D) by random assignment to one of four sequences (ABCD, BDAC, CADB, or DCBA). These treatments will be separated by a washout period of at least 7 days.
The four treatments consist of the following:
1. Treatment ATherapeutic dose of RO XXXXXXX Treatment ( data not provided)
2. Treatment B:Supratherapeutic dose of RO XXXXXXX Treatment (data not provided)
3. Treatment CActive comparator Treatment - 400 mg moxifloxacin capsule
4. Treatment DPlacebo Treatment
The total duration of the study is up to 9 weeks (from screening through study completion) for each enrolled subject as follows:
Screening: Up to 4 weeks
Dosing periods: 4 weeks (1 week washout period between each dosing)
Follow-up: 7 (+3) days after last dosing (study completion)
The end of the trial is defined as the date of the last visit or receipt of last data point for statistical analysis of the last subject undergoing the trial.
Note: four patients have only one Holter ECG, they are the patients 2382, 4986, 6105 and 9545.
Pharmacokinetic and Pharmacodynamic Evaluations: Plasma concentation, time of peak concentration and many other information are available. Please see the list below.
The QRS detection and beat annotations were obtained using Mortara E-Scribe software, annotations were manually reviewed.
File Naming Convention: The filename are based on the keycode provided below.
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List of Epochs availble for each Holter recordings: Each Holter recordings includes a set of 11 Epochs defined as follow: Remark: 14 time points can be found in the clinical data file, the 23 and 24 hour post-dosing will not been included in the warehouse. |
| -1 H : one hour predose |
| -0.5 H: 30 minutes predose |
| PREDOSE |
| 1 H: one hour postdose |
| 2 H: two hour postdose |
| 3 H: three hour postdose |
| 4 H: four hour postdose |
| 5 H: five hour postdose |
| 6 H: Six hour predose |
| 8 H: seven hours predose |
| 12 H: twelve hour predose |
Number of Leads: 12 lead Holter ECGs
Sampling Frequency : 1,000Hz
Amplitude Resolution: 3.75 uV
Clinical Information: The list of clinical information available for this study are described in the following tables:
Excel Files avalable for this study (files are availble in both SAS and MS Excel formats):
| THEWDEMO | Demography dataset |
| THEWFOOD | Meal completion dataset |
| THEWHECG | Holter ECG dataset |
| THEWMEDT | Dosing dataset |
| THEWPCON | Moxifloxacin plasma concentration |
| THEWPPAR | PK derived variables for Moxifloxacin |
List of codes for clicninal parameters available in this study:
| File Name | Variable | Label | Comments |
|---|---|---|---|
| THEWDEMO | AGE | Age (years) at randomisation | Derived: difference between the first trial medication date MEDT.MTBEGDC on CRF page 9 and DEMO.BIRTHDC on CRF page 1 |
| THEWDEMO | SEX | Sex | Gender: MALE or FEMALE |
| THEWDEMO | DUMPT | Dummy patient number | |
| THEWDEMO | DUMCRTN | Dummy Clinical Research Task number | |
| THEWFOOD | FOTYPE | Food type | Type of food and nominal time: LUNCH (4H) or DINNER (8H) |
| THEWFOOD | FOENDDC | End date of food | Meal completion date |
| THEWFOOD | FOENDTC | End time of food | Meal completion time |
| THEWFOOD | DUMPT | Dummy patient number | |
| THEWFOOD | DUMCRTN | Dummy Clinical Research Task number | |
| THEWHECG | EFDC | Date of Assessment | ECG extraction date |
| THEWHECG | EFTC | Time of assessment | Actual ECG extraction time, used the last triplicate time |
| THEWHECG | EFSCH | Sample schedule | Nominal scheduled time |
| THEWHECG | DUMPT | Dummy patient number | |
| THEWHECG | DUMCRTN | Dummy Clinical Research Task number | |
| THEWMEDT | MTBEGDC | Beginning date of trial medication | Dosing date |
| THEWMEDT | MTTXT | Name of trial medication | Placebo or Moxifloxacin |
| THEWMEDT | MTDOSE | Dose (# of dose units) | |
| THEWMEDT | MTUN | Dose unit | |
| THEWMEDT | DUMPT | Dummy patient number | |
| THEWMEDT | DUMCRTN | Dummy Clinical Research Task number | |
| THEWPCON | PCSCHT | Scheduled sampling time (from CRF) | Nominal scheduled time |
| THEWPCON | PCDC | Date of sampling | Moxifloxacin plasma concentration sampling date |
| THEWPCON | PCTC | Time of sampling | Actual Moxifloxacin plasma concentration sampling time |
| THEWPCON | PCSPEC | Specimen, matrix of sample | PLASMA |
| THEWPCON | PCANALYT | Analyte | MOXIFLOXACIN |
| THEWPCON | PCVALC | Concentration value | Character concentration value |
| THEWPCON | PCVALN | Converted numeric concentration value | Numeric concentration value |
| THEWPCON | PCUN | Unit of concentration | |
| THEWPCON | DUMPT | Dummy patient number | |
| THEWPCON | DUMCRTN | Dummy Clinical Research Task number | |
| THEWPPAR | PPANALYT | Analyte | MOXIFLOXACIN |
| THEWPPAR | PPDESCR | Parameter description | Detailed parameter description |
| THEWPPAR | PPOUT | Parameter output label | Parameter short name |
| THEWPPAR | PPVALN | Numeric value of parameter | Derived value |
| THEWPPAR | PPUN | Unit of derived parameter | |
| THEWPPAR | DUMPT | Dummy patient number | |
| THEWPPAR | DUMCRTN | Dummy Clinical Research Task number |