Thorough QT Study # 1 |
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IDENTIFICATION : E-HOL-03-0102-005 |
Study Design: The study was a double-blind, randomised, 5-way crossover study. The study consisted of a single cohort of 35 subjects. Each subject was randomised to one of 10 possible sequences of treatment and received a single dose of Unknown Compound (UnC): 30mg / 100mg and 300mg. Placebo or moxifloxacin was given on five occasions, each being 10-14 days apart. During each study period subjects were resident for two nights/three days and a follow-up visit occurred 10-14 days after the final administration. A run-in day, independent from the randomisation was included in Period 3 requiring an additional one night/one day residency during which subjects were administered a single blinded placebo dose.
Inclusion Criteria: Healthy male and female subjects, between age 18 to 55 years, inclusive body mass index is approximatively 18 to 30 Kg/m*m and total body weight >50kg were enrolled in the study.
Study Treatment: A single oral dose of UnC tablets (30, 100 and 300mg), placebo or a single moxifloxacin tablet (400mg) was administered on five separate occasions with 10-14 days between each study period.
Pharmacokinetic and Pharmacodynamic Evaluations: Pharmacokinetic evaluations: Blood samples were obtained from subjects at protocol specified intervals of time to calculate the AUC24, Cmax, and Tmax for UnC. Pharmacodynamic evaluations: ECG measurements were recorded at the protocol specified times before the pharmacokinetic blood samples were collected (within five minutes of the ECG), after subjects had been resting semi-recumbent for at least 10 minutes. Holter monitoring was performed on Day 1 (Period 3 only) and Day 1 (all periods) from pre-dose to approximately eight hours post-dose.
The QRS detection and beat annotations were obtained using Philips Holter System.
File Naming Convention: Each filename is composed by Individual ID and arm ID. For instance, the Holter ECG from the individual ID=33, recorded in the placebo arm is called "33-pbo". Three arms from this study are included in the warehouse : 300mg,moxi and pbo corresponding to the arms fro the unknown compound, moxifloxacin and placebo, respectively.
Global Epochs: Each Holter recordings includes an epoch called "4-hour post dosing" which indicates the start time of dosing and the end time of a 4-hour long time interval after dosing.
Number of Leads: 3 (EASI lead configuration)
Sampling Frequency : 200Hz
Amplitude Resolution: 4.9 microV
Clinical Information: The list of clinical information available for this study are described int he following table:
5 |
Unique subject number within trial (SUBJID) |
6 |
Collection date (COLLDATE) |
7 |
Age (AGE) |
8 |
Units for Age (AGEUNITS) |
9 |
Age in Days (AGEDAY) |
10 |
Age in weeks (AGEWEEK) |
11 |
Age in months (AGEMTH) |
12 |
Age in Years (AGEYR) |
14 |
Height in cm (HT) |
15 |
Height raw (HTRAW) |
16 |
Height raw units (HTUNI) |
17 |
Weight in kg (WT) |
18 |
Weight raw (WTRAW) |
19 |
Weight raw units (WTUNI) |
20 |
Race (RACES) |
21 |
Text for other race (RACEOTH) |
22 |
Original textual value of race (XRACES) |
23 |
Gender code (SEX) |
24 |
Original textual value of SEX (XSEX) |
27 |
Raw value of beer consumed (ALCBEERR) |
28 |
Units for raw beer consumed (ALCBEERU) |
30 |
Raw value of wine consumed (ALCWINER) |
31 |
Units for raw wine consumed (ALCWINEU) |
33 |
Spirits/liquor consumed-raw (ALCOTHR) |
34 |
Spirits/liquor consumed-units (ALCOTHU) |
36 |
Does the patient drink (ALCHIST2) |
37 |
Subject started smoking-years (STDUR) |
38 |
Subject started smoking-raw (STDURRAW) |
39 |
Subject started smoking-units (STDURUNI) |
40 |
Time since stopped smoking-years (SPDUR) |
41 |
Time since stopped smoking-raw (SPDURRAW) |
42 |
Time since stopped smoking-units (SPDURUNI) |
43 |
Nicotine Usage (SMOKE) |
44 |
Smoking classification (SMKCLASS) |
45 |
Amount Cigarettes smoked per day (SMKCIGTA) |
46 |
Raw amount of cigarettes smoked (SMKCIGTR) |
47 |
Cigarettes smoked-units (SMKCIGTU) |
48 |
amount Cigars smoked per day (SMKCIGA) |
49 |
Cigars smoked per day (SMKCIGR) |
50 |
Cigars smoked-units (SMKCIGU) |
51 |
Amount of Pipes smoked per day (SMKPIPEA) |
52 |
Raw amount of pipes smoked (SMKPIPER) |
53 |
Pipes smoked-units (SMKPIPEU) |
54 |
Smokes Cigarellos (SMKCRL) |
55 |
Cigarellos per day (SMKCRLA) |
56 |
Chew Tobacco (SMKCTB) |
57 |
Chew tobacco consumed per day (SMKCTBA) |
58 |
Did the subject quit due to poor health (SMKQPH) |
59 |
Visit designator (VISIT_ID) |
60 |
Country (CNTRYCOD) |
61 |
Info sheet handed to patient? (INFSHEET) |
62 |
Info sheet handed to patient? (INFSHEE2) |
63 |
Reason info sheet not handed on (INFSHTT) |
89 |
Visit (VISIT) |
90 |
COLLDAT2 (COLLDAT2) |
91 |
VISIT2 (VISIT2) |
99 |
Repeat # (REPEATSN) |
107 |
SUBJECT SMOKE CIGARS-DVN (SMKCIG) |
108 |
SUBJECT SMOKE CIGARETTES-DVN (SMKCIGT) |
109 |
SUBJECT SMOKE A PIPE-DVN (SMKPIPE) |