Trial Outcomes & Findings for A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937) (NCT NCT01101464)
NCT ID: NCT01101464
Last Updated: 2022-02-09
Results Overview
The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222 Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
COMPLETED
PHASE2
8 participants
Day 5 & Day 7
2022-02-09
Participant Flow
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
Participant milestones
| Measure |
Asenapine, (3) 5mg Then (1) 15 mg
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
|
Asenapine, (1) 15 mg Then (3) 5 mg
One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
|
|---|---|---|
|
Day 1 Through AM Dose of Day 5
STARTED
|
4
|
4
|
|
Day 1 Through AM Dose of Day 5
COMPLETED
|
4
|
4
|
|
Day 1 Through AM Dose of Day 5
NOT COMPLETED
|
0
|
0
|
|
PM Dose of Day 5 Through AM Dose of Day7
STARTED
|
4
|
4
|
|
PM Dose of Day 5 Through AM Dose of Day7
COMPLETED
|
4
|
4
|
|
PM Dose of Day 5 Through AM Dose of Day7
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937)
Baseline characteristics by cohort
| Measure |
Asenapine, (3) 5 mg Then (1) 15 mg
n=4 Participants
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
|
Asenapine, (1) 15 mg Then (3) 5 mg
n=4 Participants
One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 5 & Day 7Population: All participants were included in both treatment comparisons (as per cross over design).
The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222 Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
Outcome measures
| Measure |
Asenapine 3x5mg
n=8 Participants
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
|
Asenapine 1x15mg
n=8 Participants
One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
|
|---|---|---|
|
Pharmacokinetic Parameter of Maximum Plasma Concentration (Cmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)
|
6.89 ng/mL
Standard Deviation 3.08
|
6.38 ng/mL
Standard Deviation 2.76
|
PRIMARY outcome
Timeframe: Day 5 & Day 7Population: All participants were included in both treatment comparisons (as per cross over design).
The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2
Outcome measures
| Measure |
Asenapine 3x5mg
n=8 Participants
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
|
Asenapine 1x15mg
n=8 Participants
One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
|
|---|---|---|
|
Pharmacokinetic Parameter of Time of Occurrence of Cmax (Tmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)
|
1.25 Hours
Interval 0.5 to 2.0
|
1.00 Hours
Interval 0.5 to 3.0
|
PRIMARY outcome
Timeframe: Day 5 & Day 7Population: All participants were included in both treatment comparisons (as per cross over design).
The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
Outcome measures
| Measure |
Asenapine 3x5mg
n=8 Participants
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
|
Asenapine 1x15mg
n=8 Participants
One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
|
|---|---|---|
|
Pharmacokinetic Parameter of Area Under the Curve (AUC) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)
|
41.3 ng*h/mL
Standard Deviation 18.2
|
41.1 ng*h/mL
Standard Deviation 17.1
|
Adverse Events
Asenapine, (3) 5 mg Then (1) 15 mg
Asenapine, (1) 15 mg Then (3) 5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asenapine, (3) 5 mg Then (1) 15 mg
n=4 participants at risk
Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
|
Asenapine, (1) 15 mg Then (3) 5 mg
n=4 participants at risk
One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
|
Nervous system disorders
Extrapyramidal disosrder
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
25.0%
1/4 • Number of events 1
All subjects rec'd asenapine 5mg BID on Day 1 \& 10mg BID on Day 2. Subjects rec'd 15mg BID (either 3x5mg or 1x15mg according to their randomized sequence) from the morning dose on Day 3 through the morning dose on Day 5, followed by the alternate treatment (either 3x5mg or 1x15mg) from the evening dose on Day 5 through the morning dose on Day 7.
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee All publications must be based on data validated by Organon. Any such communication will first be submitted to Organon, at least 6 weeks ahead of time for written consent. Organon shall have the right to make its consent conditional upon proper representation of the interpretation of both Organon and the investigator. In any communication concerning this trial, the authors of this protocol will be included in the list of authors.
- Publication restrictions are in place
Restriction type: OTHER