Trial Outcomes & Findings for A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults (NCT NCT06132867)
NCT ID: NCT06132867
Last Updated: 2025-01-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dose
Results posted on
2025-01-23
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 20 December 2023 to 17 February 2024.
A total of 12 participants entered the study and were randomized in a 1:1 ratio to one of the treatment sequences: Treatment A followed by Treatment B (AB) or Treatment B followed by Treatment A (BA).
Participant milestones
| Measure |
Sequence AB
Participants received single dose of brigatinib 90 milligram (mg) as an oral solution in a fasted state on Day 1 of Period 1 (Treatment A) followed by single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 2 (Treatment B). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.
|
Sequence BA
Participants received single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 1 (Treatment B) followed by single dose of brigatinib 90 mg as an oral solution in a fasted state on Day 1 of Period 2 (Treatment A). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.
|
|---|---|---|
|
Period 1 (Day 1)
STARTED
|
6
|
6
|
|
Period 1 (Day 1)
COMPLETED
|
6
|
6
|
|
Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Day 1)
STARTED
|
6
|
6
|
|
Period 2 (Day 1)
COMPLETED
|
6
|
6
|
|
Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults
Baseline characteristics by cohort
| Measure |
Sequence AB
n=6 Participants
Participants received single dose of brigatinib 90 milligram (mg) as an oral solution in a fasted state on Day 1 of Period 1 (Treatment A) followed by single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 2 (Treatment B). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.
|
Sequence BA
n=6 Participants
Participants received single dose of brigatinib 90 mg as an immediate-release tablet in a fasted state on Day 1 of Period 1 (Treatment B) followed by single dose of brigatinib 90 mg as an oral solution in a fasted state on Day 1 of Period 2 (Treatment A). A washout period of at least 14 days was maintained between brigatinib administration in Period 1 and 2.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: Brigatinib 90 mg Oral Solution
n=12 Participants
Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.
|
Treatment B: Brigatinib 90 mg Tablet
n=12 Participants
Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Brigatinib
|
366.6 nanogram per millliliter (ng/mL)
Geometric Coefficient of Variation 53.2
|
397.6 nanogram per millliliter (ng/mL)
Geometric Coefficient of Variation 49.7
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dosePopulation: The PK analysis set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: Brigatinib 90 mg Oral Solution
n=12 Participants
Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.
|
Treatment B: Brigatinib 90 mg Tablet
n=12 Participants
Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.
|
|---|---|---|
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Brigatinib
|
6930 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 43.4
|
7219 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 43.6
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post-dosePopulation: The PK analysis set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: Brigatinib 90 mg Oral Solution
n=12 Participants
Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.
|
Treatment B: Brigatinib 90 mg Tablet
n=12 Participants
Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.
|
|---|---|---|
|
AUCinf: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity for Brigatinib
|
7373 ng*h/mL
Geometric Coefficient of Variation 39.5
|
7693 ng*h/mL
Geometric Coefficient of Variation 41.0
|
SECONDARY outcome
Timeframe: From first dose of the study drug up to Day 31Population: The safety analysis set included all the participants who received at least one dose of the study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who had signed informed consent form (ICF) to participate in a study. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event that was starting or worsening at the time of or after the first dose of brigatinib administered in the study. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or is an important medical event.
Outcome measures
| Measure |
Treatment A: Brigatinib 90 mg Oral Solution
n=12 Participants
Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.
|
Treatment B: Brigatinib 90 mg Tablet
n=12 Participants
Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
2 Participants
|
2 Participants
|
|
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A: Brigatinib 90 mg Oral Solution
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: Brigatinib 90 mg Tablet
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: Brigatinib 90 mg Oral Solution
n=12 participants at risk
Participants received single dose of brigatinib 90 mg as an oral solution on Day 1 of Period 1 or 2 in a fasted state.
|
Treatment B: Brigatinib 90 mg Tablet
n=12 participants at risk
Participants received single dose of brigatinib 90 mg as an immediate-release tablet on Day 1 of Period 1 or 2 in a fasted state.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
8.3%
1/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • From first dose of the study drug up to Day 31
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER