Trial Outcomes & Findings for Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183) (NCT NCT01111851)
NCT ID: NCT01111851
Last Updated: 2015-02-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
24 hours post dose
Results posted on
2015-02-25
Participant Flow
Aprepitant 250 mg was not evaluated because the assessment of the positron emission tomography (PET) scan data (neurokinin 1 (NK1)-receptor occupancy values at 24 \& 48 hours postdose) from fosaprepitant 150 mg \& aprepitant 165 mg revealed that the protocol's hypothesis was met; therefore, it was not necessary to evaluate aprepitant 250 mg.
Participant milestones
| Measure |
Fosaprepitant 150 mg
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Fosaprepitant 150 mg
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Overall Study
All planned PET scans were not obtained.
|
2
|
0
|
Baseline Characteristics
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
Baseline characteristics by cohort
| Measure |
Fosaprepitant 150 mg
n=8 Participants
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
n=8 Participants
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< = 18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
Between 18 and 55 years
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Age, Customized
> = 55 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
16 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hours post dosePopulation: All participants with at least 1 successful post dose PET scan were included in the analysis population.
Outcome measures
| Measure |
Fosaprepitant 150 mg
n=5 Participants
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
n=5 Participants
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Brain NK1-receptor Occupancy at 24 Hours Post Dose
|
100.40 Percent of occupancy
Interval 99.51 to 101.29
|
100.20 Percent of occupancy
Interval 99.31 to 101.09
|
PRIMARY outcome
Timeframe: 48 hours post dosePopulation: All participants with at least 1 successful postdose PET scan were included in the analysis population.
Outcome measures
| Measure |
Fosaprepitant 150 mg
n=4 Participants
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
n=5 Participants
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Brain NK1-receptor Occupancy at 48 Hours Post Dose
|
98.62 Percent of occupancy
Interval 96.91 to 100.37
|
98.79 Percent of occupancy
Interval 97.19 to 100.42
|
SECONDARY outcome
Timeframe: 30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitantPopulation: All participants with at least 1 successful postdose PET scan were included in the analysis population.
Outcome measures
| Measure |
Fosaprepitant 150 mg
n=2 Participants
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
n=3 Participants
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)
|
100.25 Percent of occupancy
Interval 97.22 to 103.39
|
99.99 Percent of occupancy
Interval 97.47 to 102.58
|
SECONDARY outcome
Timeframe: 120 hours post dosePopulation: All participants with at least 1 successful postdose PET scan were included in the analysis population.
Outcome measures
| Measure |
Fosaprepitant 150 mg
n=3 Participants
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
n=3 Participants
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Brain NK1-receptor Occupancy at 120 Hours Post Dose
|
59.93 Percent of occupancy
Interval 34.37 to 104.49
|
54.32 Percent of occupancy
Interval 31.15 to 94.71
|
Adverse Events
Fosaprepitant 150 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Aprepitant 165 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fosaprepitant 150 mg
n=8 participants at risk
A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
Aprepitant 165 mg
n=8 participants at risk
A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
12.5%
1/8
|
12.5%
1/8
|
|
Eye disorders
Visual impairment
|
0.00%
0/8
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8
|
50.0%
4/8
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
12.5%
1/8
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
2/8
|
50.0%
4/8
|
|
General disorders
Fatigue
|
0.00%
0/8
|
12.5%
1/8
|
|
General disorders
Influenza like illness
|
0.00%
0/8
|
12.5%
1/8
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8
|
12.5%
1/8
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8
|
12.5%
1/8
|
|
Investigations
Positron emission tomogram abnormal
|
0.00%
0/8
|
12.5%
1/8
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8
|
12.5%
1/8
|
|
Nervous system disorders
Dizziness postural
|
12.5%
1/8
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
25.0%
2/8
|
0.00%
0/8
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
12.5%
1/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
1/8
|
50.0%
4/8
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8
|
12.5%
1/8
|
|
Vascular disorders
Flushing
|
37.5%
3/8
|
12.5%
1/8
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER