Trial Outcomes & Findings for A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential (NCT NCT03807739)
NCT ID: NCT03807739
Last Updated: 2020-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.
Results posted on
2020-08-31
Participant Flow
Screening period: Day -28 to Day 2
Participant milestones
| Measure |
Part 1: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation
In Part 1 participants received single doses of either GDC-0134 F09 or GDC-0134 F16 capsules (prototype) after having consumed a standard meal.
|
Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation
In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.
|
Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation
In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.
|
Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation
In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
9
|
10
|
|
Overall Study
COMPLETED
|
7
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation
In Part 1 participants received single doses of either GDC-0134 F09 or GDC-0134 F16 capsules (prototype) after having consumed a standard meal.
|
Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation
In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.
|
Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation
In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.
|
Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation
In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Baseline characteristics by cohort
| Measure |
Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation
n=9 Participants
In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.
|
Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation
n=10 Participants
In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.
|
Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation
n=9 Participants
In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.
|
Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation
n=10 Participants
In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
52.6 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
56.1 Years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Weight
|
74.5 kg
STANDARD_DEVIATION 12.5 • n=5 Participants
|
68.9 kg
STANDARD_DEVIATION 10.9 • n=7 Participants
|
73.4 kg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
71.5 kg
STANDARD_DEVIATION 10.0 • n=4 Participants
|
72.0 kg
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Height
|
162.9 cm
STANDARD_DEVIATION 7.6 • n=5 Participants
|
161.2 cm
STANDARD_DEVIATION 5.8 • n=7 Participants
|
159.1 cm
STANDARD_DEVIATION 6.6 • n=5 Participants
|
160.6 cm
STANDARD_DEVIATION 5.0 • n=4 Participants
|
160.9 cm
STANDARD_DEVIATION 6.2 • n=21 Participants
|
|
BMI
|
28.1 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
159.1 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 5.1 • n=4 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.Outcome measures
| Measure |
Part 1 GDC-0134 F16 Capsule Fed
n=18 Participants
In Part 1 participants received single doses of GDC-0134 F16 after having consumed a standard meal.
|
Part 1 GDC-0134 F09 Capsule Fed
n=19 Participants
In Part I participants received single doses of GDC-0134 F09 capsules after having consumed a standard meal.
|
Part 2 GDC-0134 F15 Fasted
n=19 Participants
In Part 2, participants received a single dose of GDC-0134 F15 capsules after an overnight fast.
|
Part 2 GDC-0134 F09 Capsule Fasted
n=19 Participants
In Part 2, participants received a single dose of GDC-0134 F09 capsules after an overnight fast.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of GDC-0134.
|
5.56 uM
Geometric Coefficient of Variation 85.2
|
4.45 uM
Geometric Coefficient of Variation 93.7
|
2.66 uM
Geometric Coefficient of Variation 131.5
|
2.68 uM
Geometric Coefficient of Variation 140.1
|
PRIMARY outcome
Timeframe: The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.Outcome measures
| Measure |
Part 1 GDC-0134 F16 Capsule Fed
n=18 Participants
In Part 1 participants received single doses of GDC-0134 F16 after having consumed a standard meal.
|
Part 1 GDC-0134 F09 Capsule Fed
n=19 Participants
In Part I participants received single doses of GDC-0134 F09 capsules after having consumed a standard meal.
|
Part 2 GDC-0134 F15 Fasted
n=19 Participants
In Part 2, participants received a single dose of GDC-0134 F15 capsules after an overnight fast.
|
Part 2 GDC-0134 F09 Capsule Fasted
n=19 Participants
In Part 2, participants received a single dose of GDC-0134 F09 capsules after an overnight fast.
|
|---|---|---|---|---|
|
Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134
|
190 uM.h
Geometric Coefficient of Variation 78.7
|
154 uM.h
Geometric Coefficient of Variation 94.9
|
84.8 uM.h
Geometric Coefficient of Variation 103.4
|
85.6 uM.h
Geometric Coefficient of Variation 103.9
|
SECONDARY outcome
Timeframe: From baseline through the end of study (approximately 11 weeks)Outcome measures
| Measure |
Part 1 GDC-0134 F16 Capsule Fed
n=19 Participants
In Part 1 participants received single doses of GDC-0134 F16 after having consumed a standard meal.
|
Part 1 GDC-0134 F09 Capsule Fed
n=19 Participants
In Part I participants received single doses of GDC-0134 F09 capsules after having consumed a standard meal.
|
Part 2 GDC-0134 F15 Fasted
In Part 2, participants received a single dose of GDC-0134 F15 capsules after an overnight fast.
|
Part 2 GDC-0134 F09 Capsule Fasted
In Part 2, participants received a single dose of GDC-0134 F09 capsules after an overnight fast.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
63.2 Percentage of Participants
|
52.6 Percentage of Participants
|
—
|
—
|
Adverse Events
Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part II: GDC-0134 F15 vs F09 Capsule Formulation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation
n=19 participants at risk
In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.
|
Part II: GDC-0134 F15 vs F09 Capsule Formulation
n=19 participants at risk
In Part 2, participants received a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.
|
|---|---|---|
|
Nervous system disorders
Headache
|
36.8%
7/19 • Number of events 9 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
36.8%
7/19 • Number of events 8 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
15.8%
3/19 • Number of events 3 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
15.8%
3/19 • Number of events 3 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 2 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
21.1%
4/19 • Number of events 5 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
21.1%
4/19 • Number of events 4 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Investigations
Haemoglobin decreased
|
10.5%
2/19 • Number of events 4 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Investigations
Haematocrit decreased
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Investigations
Mean cell volume decreased
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
General disorders
Vessel puncture site swelling
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
General disorders
Fatigue
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
15.8%
3/19 • Number of events 3 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
General disorders
Asthenia
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Eye disorders
Eye pain
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/19 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
5.3%
1/19 • Number of events 1 • From baseline up to 4 months
The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER