Trial Outcomes & Findings for A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants (NCT NCT04965389)
NCT ID: NCT04965389
Last Updated: 2023-08-21
Results Overview
Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Treatment Sequence 1: ABCED
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (B) milvexian SDD high dose capsules in the fasted state, (C) milvexian SDD low dose capsules in the fed state, (E) milvexian SDD high dose capsules in the fed state, and (D) milvexian SDD low dose capsules in the fasted state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 2: ACDBE
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (C) milvexian SDD low dose capsules in the fed state, (D) milvexian SDD low dose capsules in the fasted state, (B) milvexian SDD high dose capsules in the fasted state, and (E) milvexian SDD high dose capsules in the fed state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 3: ADECB
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (D) milvexian SDD low dose capsules in the fasted state, (E) milvexian SDD high dose capsules in the fed state, (C) milvexian SDD low dose capsules in the fed state, (B) milvexian SDD high dose capsules in the fasted state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 4: AEBDC
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (E) milvexian SDD high dose capsules in the fed state, (B) milvexian SDD high dose capsules in the fasted state, (D) milvexian SDD low dose capsules in the fasted state, (C) milvexian SDD low dose capsules in the fed state with a minimum of 72 hour washout in between each treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
4
|
4
|
|
Overall Study
Participants Completed Treatment Period 1
|
4
|
5
|
4
|
4
|
|
Overall Study
Participants Completed Treatment Period 2
|
4
|
4
|
4
|
4
|
|
Overall Study
Participants Completed Treatment Period 3
|
3
|
4
|
4
|
4
|
|
Overall Study
Participants Completed Treatment Period 4
|
3
|
3
|
4
|
4
|
|
Overall Study
Participants Completed Treatment Period 5
|
3
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1: ABCED
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (B) milvexian SDD high dose capsules in the fasted state, (C) milvexian SDD low dose capsules in the fed state, (E) milvexian SDD high dose capsules in the fed state, and (D) milvexian SDD low dose capsules in the fasted state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 2: ACDBE
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (C) milvexian SDD low dose capsules in the fed state, (D) milvexian SDD low dose capsules in the fasted state, (B) milvexian SDD high dose capsules in the fasted state, and (E) milvexian SDD high dose capsules in the fed state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 3: ADECB
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (D) milvexian SDD low dose capsules in the fasted state, (E) milvexian SDD high dose capsules in the fed state, (C) milvexian SDD low dose capsules in the fed state, (B) milvexian SDD high dose capsules in the fasted state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 4: AEBDC
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (E) milvexian SDD high dose capsules in the fed state, (B) milvexian SDD high dose capsules in the fasted state, (D) milvexian SDD low dose capsules in the fasted state, (C) milvexian SDD low dose capsules in the fed state with a minimum of 72 hour washout in between each treatment period.
|
|---|---|---|---|---|
|
Overall Study
Other reasons
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant withdrew consent
|
0
|
1
|
0
|
0
|
|
Overall Study
Poor/Non-compliance
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: ABCED
n=4 Participants
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (B) milvexian SDD high dose capsules in the fasted state, (C) milvexian SDD low dose capsules in the fed state, (E) milvexian SDD high dose capsules in the fed state, and (D) milvexian SDD low dose capsules in the fasted state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 2: ACDBE
n=5 Participants
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (C) milvexian SDD low dose capsules in the fed state, (D) milvexian SDD low dose capsules in the fasted state, (B) milvexian SDD high dose capsules in the fasted state, and (E) milvexian SDD high dose capsules in the fed state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 3: ADECB
n=4 Participants
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (D) milvexian SDD low dose capsules in the fasted state, (E) milvexian SDD high dose capsules in the fed state, (C) milvexian SDD low dose capsules in the fed state, (B) milvexian SDD high dose capsules in the fasted state with a minimum of 72 hour washout in between each treatment period.
|
Treatment Sequence 4: AEBDC
n=4 Participants
On Day 1 of Treatment Period 1 all participants will receive the (A) milvexian oral solution in the fasted state, followed 1 hour later by the intravenous (IV) \[14C\]milvexian microdose infused over 15 minutes. On Day 1 for Treatment Periods 2 to 5, participants will receive (E) milvexian SDD high dose capsules in the fed state, (B) milvexian SDD high dose capsules in the fasted state, (D) milvexian SDD low dose capsules in the fasted state, (C) milvexian SDD low dose capsules in the fed state with a minimum of 72 hour washout in between each treatment period.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.0 Years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
45.4 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
45.8 Years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
37.3 Years
STANDARD_DEVIATION 16.2 • n=4 Participants
|
42.3 Years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: Evaluable PK population-all participants who received at least one dose of study drug and had any available concentration-time data with adequate PK profiles for accurate estimation of PK parameters
Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Absolute Bioavailability (F)
|
105 Percentage of drug
Interval 103.0 to 109.0
|
54.2 Percentage of drug
Interval 48.9 to 63.7
|
44.3 Percentage of drug
Interval 39.6 to 53.0
|
58.2 Percentage of drug
Interval 52.8 to 70.7
|
75.6 Percentage of drug
Interval 71.1 to 81.8
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)Population: All treated participants
The number of participants experiencing AEs following single oral and IV administration. AEs are defined as any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=17 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Total participants with an adverse event
|
8 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Adverse events leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)Population: All treated participants
The number of participants experiencing SAEs following single oral and IV administration. SAEs are defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=17 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All treated participants
Occurrence of abnormalities in vital sign measurements exceeding pre-defined thresholds following single oral and IV administration. The pre-defined thresholds include: Heart Rate(bpm) Value \> 100 and change from baseline \> 30, or Value \< 55 and change from baseline \< -15 Systolic Blood Pressure(mmHg) Value \> 140 and change from baseline \> 20, or Value \< 90 and change from baseline \< -20 Diastolic Blood Pressure(mmHg) Value \> 90 and change from baseline \> 10, or Value \< 55 and change from baseline \< -10 Respiratory Rate(breaths/min) Value \> 16 or change from baseline \> 10 Temperature (°C) Value \> 38.3°C or change from baseline \> 1.6°C
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=17 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Heart Rate (bpm) Value > 100 and change from baseline > 30
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Heart Rate (bpm) Value < 55 and change from baseline < -15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Systolic Blood Pressure (mmHg) Value > 140 and change from baseline > 20
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Systolic Blood Pressure (mmHg) Value < 90 and change from baseline < -20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Diastolic Blood Pressure (mmHg) Value > 90 and change from baseline > 10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Diastolic Blood Pressure (mmHg) Value < 55 and change from baseline < -10
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Respiratory Rate (breaths/min) Value > 16 or change from baseline > 10
|
13 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants Experiencing Abnormal Vital Sign Measurements
Temperature (°C)Value > 38.3°C or change from baseline > 1.6°C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All treated participants
The number of participants with abnormal findings on ECGs following single oral and IV administration. Participants with ECG intervals outside of a pre-specified range and investigator identified ECG abnormalities will be listed. The following criteria will be used to determine ECG results that are outside of a pre-specified range: PR (msec)-Value \> 200; QRS (msec)-Value \> 120; QT (msec)-Value \> 500 or change from baseline \> 30; QTcF (msec)-Value \> 450 or change from baseline \> 30
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=17 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All treated participants
The number of participants with abnormal findings on physical examinations following single oral and IV administration.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=17 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Examinations
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All treated participants
Number of participants with abnormalities in clinical lab test measurements exceeding pre-defined thresholds following single oral and IV administration. The pre-defined thresholds include: Alanine transaminase \> 3 × upper limit of normal (ULN) Aspartate transaminase \> 3 × ULN Alkaline phosphatase \> 1.5 × ULN Total bilirubin \> 2 × ULN
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=17 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Test Abnormalities
Alanine transaminase > 3 × upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Test Abnormalities
Aspartate transaminase > 3 × ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Test Abnormalities
Alkaline phosphatase > 1.5 × ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Test Abnormalities
Total bilirubin > 2 × ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
Cmax is defined as the maximum observed plasma concentration following single administration in the fed and fasted states to healthy participants.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
2929 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25.3
|
1200 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31.0
|
130 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40.6
|
185 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 34.7
|
1696 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 24.5
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
Tmax is defined as the time of maximum observed plasma concentration in the fed and fasted states to healthy participants.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Time of Maximum Observed Plasma Concentration (Tmax)
|
1.27 Hours
Interval 0.5 to 4.0
|
4.00 Hours
Interval 1.5 to 5.0
|
4.00 Hours
Interval 1.0 to 6.0
|
4.00 Hours
Interval 1.25 to 6.0
|
5.00 Hours
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration following single administration in the fed and fasted states to healthy participants.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
|
30844 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 24.2
|
15855 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 33.4
|
1603 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 51.2
|
2183 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 60.6
|
21972 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25.1
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity following single administration in the fed and fasted states to healthy participants
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(INF)]
|
31435 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25.3
|
16464 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 35.6
|
1569 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40.0
|
2061 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 32.6
|
22496 ng.h/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28.6
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
CLT/F is defined as the apparent clearance of drug after extravascular administration.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Apparent Clearance of Drug After Extravascular Administration (CLT/F)
|
6.36 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25.3
|
12.1 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 36.9
|
15.9 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 39.1
|
12.1 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 44.0
|
8.89 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 26.1
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
CLR is defined as the volume of plasma completely cleared of a substance by the kidneys per unit of time, in this case by hour.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Renal Clearance (CLR)
|
1.63 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31.3
|
1.68 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 31.6
|
1.91 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 29.0
|
1.84 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 27.4
|
1.70 Liters/hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 30.3
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
Vz/F is defined as the apparent volume of distribution at terminal phase after extravascular administration.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F)
|
121 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25.8
|
243 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 37.2
|
344 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 40.9
|
245 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 45.1
|
159 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 15.3
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
Ae is defined as the total amount of unchanged drug excreted into the urine following single administration in the fed and fasted states to healthy participants
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Total Amount of Unchanged Drug Excreted Into the Urine (Ae)
|
50.2 mg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21.7
|
26.7 mg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28.0
|
3.06 mg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43.7
|
4.01 mg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 42.8
|
37.3 mg
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20.6
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
%UR is defined as a percent or absolute amount of dose that is recovered in the urine as the unchanged drug.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Total Percent Urinary Recovery (%UR)
|
25.1 Percentage of milvexian recovered
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21.7
|
13.3 Percentage of milvexian recovered
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28.0
|
12.2 Percentage of milvexian recovered
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 43.7
|
16.0 Percentage of milvexian recovered
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 42.8
|
18.6 Percentage of milvexian recovered
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20.6
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
T-HALF is defined as the time required for half the quantity of a drug to be metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Half-life (T-HALF)
|
13.3 Hours
Standard Deviation 2.02
|
14.3 Hours
Standard Deviation 4.08
|
15.8 Hours
Standard Deviation 6.13
|
14.5 Hours
Standard Deviation 4.10
|
12.8 Hours
Standard Deviation 3.65
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of Treatment A with evaluable concentration-time data
Mean residence time (MRT) represents the average time the drug stays in the body and is evaluated for the IV dose of Treatment A only.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Mean Residence Time (MRT) Following an IV Dose in Treatment A
|
14.8 Hours
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of Treatment A with evaluable concentration-time data
Characterize the IV dose of Treatment A by Vss, which is defined as the apparent volume of distribution at steady state
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) Following an IV Dose in Treatment A
|
99.1 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 15.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
Point estimates and 90% CI for the ratio of geometric means for Cmax will be constructed for the comparison of each milvexian capsule treatment (Treatments B, C, D, and E) separately versus the oral solution (Treatment A). No data is reported for Treatment A because it is the comparison treatment. Relative bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to a different formulation (non-IV) such as an oral solution. Cmax is defined as the maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Relative Bioavailability (Frel) Based on Ratios of Cmax
|
NA ng/mL
Data is not provided for Treatment A because it is the comparator for the other treatments and therefore could not be compared to itself.
|
0.403 ng/mL
Interval 0.354 to 0.459
|
0.358 ng/mL
Interval 0.307 to 0.418
|
0.510 ng/mL
Interval 0.427 to 0.61
|
0.574 ng/mL
Interval 0.524 to 0.629
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of study drug with evaluable concentration-time data
Point estimates and 90% CI for the ratio of geometric means for AUC(0-T) and AUC(INF) will be constructed for the comparison of each milvexian capsule treatment (Treatments B, C, D, and E) separately versus the oral solution (Treatment A). No data is reported for Treatment A because it is the comparison treatment. Relative bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to a different formulation (non-IV) such as an oral solution. AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=16 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 Participants
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Relative Bioavailability (Frel) Based on Ratios of AUC(0-T) and AUC(INF)
AUC(0-T)
|
NA ng.h/mL
Data is not provided for Treatment A because it is the comparator for the other treatments and therefore could not be compared to itself.
|
0.513 ng.h/mL
Interval 0.446 to 0.591
|
0.425 ng.h/mL
Interval 0.367 to 0.492
|
0.570 ng.h/mL
Interval 0.466 to 0.697
|
0.716 ng.h/mL
Interval 0.661 to 0.775
|
|
Relative Bioavailability (Frel) Based on Ratios of AUC(0-T) and AUC(INF)
AUC(INF)
|
NA ng.h/mL
Data is not provided for Treatment A because it is the comparator for the other treatments and therefore could not be compared to itself.
|
0.522 ng.h/mL
Interval 0.455 to 0.6
|
0.436 ng.h/mL
Interval 0.375 to 0.507
|
0.543 ng.h/mL
Interval 0.453 to 0.651
|
0.720 ng.h/mL
Interval 0.664 to 0.78
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of Treatment B, C, D, or E with evaluable concentration-time data
Food effect analysis of the high and low dose SDD capsules based on ratios of Cmax. The food effect analysis will be run separately for each dose level. For the low dose level, low dose milvexian SDD fed (Treatment C) is the test treatment and low dose milvexian SDD fasted (Treatment D) is the reference treatment. For the high dose dose level, high dose milvexian SDD fed (Treatment E) is the test treatment and high dose milvexian SDD fasted (Treatment B) is the reference treatment. Cmax is defined as the maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=15 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Food Effect Based on Ratios of Cmax Following an SDD Capsule Dose in Treatment B, C, D, and E
|
1197 ng/mL
Interval 1039.0 to 1378.0
|
128 ng/mL
Interval 105.0 to 156.0
|
185 ng/mL
Interval 153.0 to 223.0
|
1709 ng/mL
Interval 1521.0 to 1920.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)Population: All participants who received at least one dose of Treatment B, C, D, or E with evaluable concentration-time data
Food effect with low and high dose SDD capsules based on ratios of AUC(0-T) and AUC(INF). The food effect analysis will be run separately for each dose level. For the low dose level, low dose milvexian SDD fed (Treatment C) is the test treatment and low dose milvexian SDD fasted (Treatment D) is the reference treatment. For the high dose level, high dose milvexian SDD fed (Treatment E) is the test treatment and high dose milvexian SDD fasted (Treatment B) is the reference treatment. AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity.
Outcome measures
| Measure |
Treatment A: Oral Solution With IV
n=15 Participants
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 Participants
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=14 Participants
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Food Effect Based on Ratios of AUC(0-T) and AUC(INF) Following an SDD Capsule Dose in Treatment B, C, D, and E
AUC(0-T)
|
15871 ng.h/mL
Interval 13678.0 to 18415.0
|
1592 ng.h/mL
Interval 1287.0 to 1969.0
|
2170 ng.h/mL
Interval 1763.0 to 2670.0
|
22171 ng.h/mL
Interval 19578.0 to 25108.0
|
—
|
|
Food Effect Based on Ratios of AUC(0-T) and AUC(INF) Following an SDD Capsule Dose in Treatment B, C, D, and E
AUC(INF)
|
16480 ng.h/mL
Interval 14067.0 to 19307.0
|
1545 ng.h/mL
Interval 1291.0 to 1848.0
|
2069 ng.h/mL
Interval 1749.0 to 2447.0
|
22774 ng.h/mL
Interval 19892.0 to 26073.0
|
—
|
Adverse Events
Treatment A: Oral Solution With IV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment B: High Dose SDD Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment C: Low Dose SDD Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment D: Low Dose SDD Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment E: High Dose SDD Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Oral Solution With IV
n=17 participants at risk
Milvexian oral solution with IV microdose
|
Treatment B: High Dose SDD Fasted
n=15 participants at risk
High dose milvexian SDD (spray-dried dispersion) was administered to a fasted population
|
Treatment C: Low Dose SDD Fed
n=15 participants at risk
Low dose milvexian SDD (spray-dried dispersion) fed
|
Treatment D: Low Dose SDD Fasted
n=15 participants at risk
Low dose milvexian SDD (spray-dried dispersion) fasted
|
Treatment E: High Dose SDD Fed
n=14 participants at risk
High dose milvexian SDD (spray-dried dispersion) fed
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.8%
2/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
6.7%
1/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
2/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
6.7%
1/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Infections and infestations
Folliculitis
|
5.9%
1/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
7.1%
1/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
6.7%
1/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
7.1%
1/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.00%
0/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
6.7%
1/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
6.7%
1/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
6.7%
1/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
7.1%
1/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/15 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
0.00%
0/14 • Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER