Thorough QT Study # 2


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.

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
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):

Demography dataset
Meal completion dataset
Holter ECG dataset
Dosing dataset
Moxifloxacin plasma concentration
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 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 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 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 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