Trial Outcomes & Findings for Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe (NCT NCT05194579)
NCT ID: NCT05194579
Last Updated: 2024-08-12
Results Overview
Cmax of PF-06881894 was defined as maximum serum concentration of PF-06881894. Observed directly from data.
COMPLETED
PHASE1
141 participants
Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
2024-08-12
Participant Flow
This was an open-label, randomized, 2-treatment (PF-06881894 via prefilled syringe \[PFS\] or PF-06881894 via on-body injector \[OBI\]), 2-period, crossover single-dose study. A total of 371 participants were screened for this study; 141 participants were randomized to treatment and treated.
Participant milestones
| Measure |
PF-06881894 PFS=>PF-06881894 OBI
Participants received PF-06881894 administered subcutaneously (SC) via PFS on Day 1 of Period 1, then followed by PF-06881894 administered SC via OBI on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments.
|
PF-06881894 OBI=>PF-06881894 PFS
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1, then followed by PF-06881894 administered SC via PFS on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
|
Overall Study
Assigned to Treatment
|
70
|
71
|
|
Overall Study
COMPLETED
|
64
|
63
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
PF-06881894 PFS=>PF-06881894 OBI
Participants received PF-06881894 administered subcutaneously (SC) via PFS on Day 1 of Period 1, then followed by PF-06881894 administered SC via OBI on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments.
|
PF-06881894 OBI=>PF-06881894 PFS
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1, then followed by PF-06881894 administered SC via PFS on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Refused further study procedures
|
0
|
1
|
|
Overall Study
Protocol deviation
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
Baseline characteristics by cohort
| Measure |
PF-06881894 PFS=>PF-06881894 OBI
n=70 Participants
Participants received PF-06881894 administered subcutaneously (SC) via PFS on Day 1 of Period 1, then followed by PF-06881894 administered SC via OBI on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments.
|
PF-06881894 OBI=>PF-06881894 PFS
n=71 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1, then followed by PF-06881894 administered SC via PFS on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 Years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
40.2 Years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
39.7 Years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index
|
26.1 kg/m^2
STANDARD_DEVIATION 2.62 • n=5 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 2.47 • n=7 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 2.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dosePopulation: The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid pharmacokinetic (PK) primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure.
Cmax of PF-06881894 was defined as maximum serum concentration of PF-06881894. Observed directly from data.
Outcome measures
| Measure |
PF-06881894 PFS
n=136 Participants
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=122 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Maximum Serum Concentration (Cmax) of PF-06881894
|
131.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 151
|
161.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 126
|
PRIMARY outcome
Timeframe: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dosePopulation: The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure.
AUClast of PF-06881894 was defined as area under the serum drug concentration-time profile from time 0 to the last quantifiable concentration. Linear/Log trapezoidal method was used.
Outcome measures
| Measure |
PF-06881894 PFS
n=136 Participants
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=122 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Area Under the Serum Drug Concentration-time Profile From Time 0 to the Last Quantifiable Concentration (AUClast) of PF-06881894
|
4510 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 152
|
5791 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 129
|
PRIMARY outcome
Timeframe: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dosePopulation: The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure.
AUCinf of PF-06881894 was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
PF-06881894 PFS
n=123 Participants
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=115 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Area Under the Serum Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06881894
|
4869 ng*hr/mL
Geometric Coefficient of Variation 128
|
6020 ng*hr/mL
Geometric Coefficient of Variation 119
|
SECONDARY outcome
Timeframe: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dosePopulation: The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure.
Tmax of PF-06881894 was defined as time for Cmax. Observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06881894 PFS
n=136 Participants
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=122 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Time for Cmax (Tmax) of PF-06881894
|
16.0 hour
Interval 6.0 to 48.1
|
16.0 hour
Interval 3.0 to 72.0
|
SECONDARY outcome
Timeframe: Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dosePopulation: The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure.
Terminal serum elimination half-life (t½) of PF-06881894 was defined as terminal half-life using Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06881894 PFS
n=123 Participants
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=115 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Terminal Serum Elimination Half-life (t½) of PF-06881894
|
45.89 hour
Standard Deviation 13.683
|
47.42 hour
Standard Deviation 14.887
|
SECONDARY outcome
Timeframe: From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).Population: All participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose). Here, 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Treatment-emergent were events between first dose and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. An AESI was one of scientific and medical concern specific to the sponsor's product or programme. Device related AE was an AE related to the use of an investigational medical device. AEs of ISR and ASR included injection site pain, injection site erythema, application site hemorrhage, application site pain, application site discomfort, application site bruise, and application site erythema.
Outcome measures
| Measure |
PF-06881894 PFS
n=136 Participants
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=136 Participants
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Adverse Event (AE)
|
101 Participants
|
107 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Device Related AE
|
3 Participants
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
AE of Injection Site Reaction (ISR) and Application Site Reaction (ASR)
|
13 Participants
|
23 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
AE of Special Interest (AESI)
|
13 Participants
|
23 Participants
|
Adverse Events
PF-06881894 PFS
PF-06881894 OBI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06881894 PFS
n=136 participants at risk
Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2.
|
PF-06881894 OBI
n=136 participants at risk
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.6%
9/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
3.7%
5/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
General disorders
Application site erythema
|
0.00%
0/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
9.6%
13/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
General disorders
Injection site pain
|
5.1%
7/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
0.00%
0/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
3/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
5.1%
7/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
32/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
19.9%
27/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.6%
24/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
18.4%
25/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
24/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
16.9%
23/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
|
Nervous system disorders
Headache
|
35.3%
48/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
37.5%
51/136 • From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER