A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.

Official Title
-----------------
A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Parallel-Group Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: GDC-0449
* Drug: moxifloxacin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, over 45 years of age In good health, as determined by the absence of clinically significant findings from the screening visit Body mass index between 18 and 32 kg/m^2 inclusive, with a body weight > 45 kg Of non-childbearing potential Exclusion Criteria: History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator Personal or family history of congenital long QT syndrome or family history of sudden death Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: moxifloxacin<br>* Oral single dose<br>Drug: placebo<br>* Oral repeating dose<br>|
| Active Comparator: B<br> | Drug: moxifloxacin<br>* Oral single dose<br>Drug: placebo<br>* Oral repeating dose<br>|
| Experimental: C<br> | Drug: GDC-0449<br>* Oral repeating dose<br>Drug: placebo<br>* Oral repeating dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The QTcF (QT interval corrected by Fridericia's correction method) |  | Throughout study or until early discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ECG from baseline |  | Throughout study or until early discontinuation | 
| Pharmacokinetic parameters of GDC-0449 |  | Throughout study or until early discontinuation | 
| Incidence, nature and severity of adverse events |  | Throughout study or until early discontinuation |