Trial Outcomes & Findings for A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males (NCT NCT03792477)
NCT ID: NCT03792477
Last Updated: 2021-04-29
Results Overview
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Results posted on
2021-04-29
Participant Flow
There were 2 parts in the study, different participants were enrolled into the 2 individual parts.
This study was a multi-period crossover study. In Part 1, there were 2 treatment periods with a washout period of 45 days. In Part 2, there were 3 treatment periods with 2 washout periods of 45 days each.
Participant milestones
| Measure |
Part 1: Treatment A>Treatment B
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (intramuscular \[IM\]) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.
|
Part 1: Treatment B>Treatment A
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.
|
Part 2: Treatment A>Treatment B>Treatment B
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.
|
Part 2: Treatment B>Treatment A>Treatment B
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.
|
Part 2: Treatment B>Treatment B>Treatment A
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
21
|
21
|
20
|
|
Overall Study
COMPLETED
|
6
|
6
|
19
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1: Treatment A>Treatment B
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (intramuscular \[IM\]) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.
|
Part 1: Treatment B>Treatment A
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.
|
Part 2: Treatment A>Treatment B>Treatment B
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.
|
Part 2: Treatment B>Treatment A>Treatment B
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.
|
Part 2: Treatment B>Treatment B>Treatment A
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
Baseline characteristics by cohort
| Measure |
Part 1: Treatment A>Treatment B
n=6 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B.
|
Part 1: Treatment B>Treatment A
n=6 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A.
|
Part 2: Treatment A>Treatment B>Treatment B
n=21 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B.
|
Part 2: Treatment B>Treatment A>Treatment B
n=21 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B.
|
Part 2: Treatment B>Treatment B>Treatment A
n=20 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<18 Years
|
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
|
0 Participants
n=10 Participants
|
|
Age, Customized
18-45 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Age, Customized
45-65 Years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
62 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
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
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.Population: The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Outcome measures
| Measure |
Treatment A
n=12 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
Treatment B
n=12 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
|---|---|---|
|
Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).
|
1444 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
1362 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
PRIMARY outcome
Timeframe: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.Population: The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Outcome measures
| Measure |
Treatment A
n=9 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
Treatment B
n=10 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
|---|---|---|
|
Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).
|
1424 ng*hr/mL
Geometric Coefficient of Variation 66
|
1392 ng*hr/mL
Geometric Coefficient of Variation 41
|
PRIMARY outcome
Timeframe: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.Population: The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.
The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Outcome measures
| Measure |
Treatment A
n=12 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
Treatment B
n=12 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
|---|---|---|
|
Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).
|
8.834 ng/mL
Geometric Coefficient of Variation 58
|
8.193 ng/mL
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.Population: The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Outcome measures
| Measure |
Treatment A
n=59 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
Treatment B
n=60 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
|---|---|---|
|
Corrected AUClast of Total Testosterone (Part 2).
|
1251 ng*hr/mL
Geometric Coefficient of Variation 59
|
1384 ng*hr/mL
Geometric Coefficient of Variation 41
|
PRIMARY outcome
Timeframe: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.Population: The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.
The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Outcome measures
| Measure |
Treatment A
n=43 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
Treatment B
n=50 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
|---|---|---|
|
Corrected AUCinf of Total Testosterone (Part 2).
|
1459 ng*hr/mL
Geometric Coefficient of Variation 44
|
1493 ng*hr/mL
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.Population: The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.
The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Outcome measures
| Measure |
Treatment A
n=59 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
Treatment B
n=60 Participants
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle.
|
|---|---|---|
|
Corrected Cmax of Total Testosterone (Part 2)
|
8.891 ng/mL
Geometric Coefficient of Variation 61
|
9.207 ng/mL
Geometric Coefficient of Variation 50
|
Adverse Events
Treatment A (Parts 1 and 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment B (Parts 1 and 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A (Parts 1 and 2)
n=71 participants at risk
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study.
|
Treatment B (Parts 1 and 2)
n=72 participants at risk
This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.8%
4/59 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
0.00%
0/60 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/12 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
8.3%
1/12 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
16.7%
2/12 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
0.00%
0/12 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
0.00%
0/12 • From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
|
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