Short Bowel Syndrome
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).
Interventions
DRUGTeduglutide
0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a 24-week treatment period in which all patients will receive teduglutide (Stage 2), and a long-term extension (Stage 3). During the long-term extension (Stage 3), patients will continue to receive teduglutide for up to an additional 24 months or until teduglutide is commercially available, whichever comes earlier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Baseline (stage 2), Week 24 | Absolute change from baseline in weekly PS volume at Week 24 was reported. |
| Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Baseline (stage 2), Week 24 | Percent change from baseline in weekly PS volume at Week 24 was reported. |
| Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2 | End of Stage 2 (up to Week 24) | Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24. |
| Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24 | Baseline (stage 2), Week 24 | Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported. |
| Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24 | Baseline (stage 2), Week 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported. |
| Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24 | Baseline (stage 2), Week 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported. |
| Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24 | Week 24 | Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported. |
| Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | Baseline (stage 3), Extension Month 24 | Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. |
| Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | Baseline (stage 3), Extension Month 24 | Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. |
| Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24 | Baseline (stage 3), Extension Month 24 | Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. |
| Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | Baseline (stage 3), Extension Month 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. |
| Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | Baseline (stage 3), Extension Month 24 | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment. |
| Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | Baseline (stage 4), End of Treatment (up to 47 months) | Absolute change from baseline in weekly PS volume at end of treatment was reported. |
| Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | Baseline (stage 4), End of Treatment (up to 47 months) | Percent change from baseline in weekly PS volume at end of treatment was reported. |
| Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment | Baseline (stage 4), End of Treatment (up to 47 months) | Absolute change from baseline in number of days per week of PS usage at end of treatment was reported. |
| Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment | Baseline (stage 4), End of Treatment (up to 47 months) | Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported. |
| Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment | Baseline (stage 4), End of Treatment (up to 47 months) | Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated. |
| Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated. |
| Maximum Concentration (Cmax) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Maximum concentration of teduglutide in plasma were evaluated. |
| Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated. |
| Terminal Half-Life (t1/2) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Terminal half-life of teduglutide in plasma were evaluated. |
| Apparent Clearance (CL/F) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Apparent clearance of teduglutide in plasma were evaluated. |
| Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma | Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose | Apparent volume of distribution of teduglutide in plasma were evaluated. |
Countries
Japan
Participant flow
Recruitment details
The study was conducted at five centers in Japan between 18 December 2014 (first participant first visit) and 12 November 2018 (last participant last visit).
Pre-assignment details
Screened participants underwent a maximum 8 week parenteral support (PS) optimization period and 4 to 8 week stabilization period (stage 1) followed by 24 weeks treatment period (stage 2), and a long-term extension period were all participants received same treatment of stage 2 in stage 3 and stage 4. Total study duration was up to 47 months.
Participants by arm
| Arm | Count |
|---|---|
| Teduglutide Optimized and stabilized participants received subcutaneous (SC) injection of teduglutide at a dose of 0.05 milligram per kilogram per day (mg/kg/day) once daily for 24 weeks during stage 2, an additional 24 months in stage 3 and continued (stage 4) until the participants entered the long-term extension study SHP633-307 (NCT03596164) or discontinued. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Discontinued with other reason | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Teduglutide |
|---|---|
| Age, Continuous | 40.9 Years STANDARD_DEVIATION 12.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 7 / 11 |
Outcome results
Primary
Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24
Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported.
Time frame: Baseline (stage 2), Week 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24 | -1.0 Days per week (days/week) | Standard Deviation 1.8 |
Primary
Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported.
Time frame: Baseline (stage 2), Week 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24 | 15.0 Micromoles per liter | Standard Deviation 17.37 |
Primary
Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Absolute change from baseline in weekly PS volume at Week 24 was reported.
Time frame: Baseline (stage 2), Week 24
Population: Intent-to-treat (ITT) population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | -4.92 Liter per week (L/week) | Standard Deviation 4.749 |
Primary
Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24
Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported.
Time frame: Week 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Teduglutide | Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24 | 0 Participants |
Primary
Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2
Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24.
Time frame: End of Stage 2 (up to Week 24)
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teduglutide | Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2 | PS Response: Yes | 45.5 Percentage of Participants |
| Teduglutide | Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2 | PS Response: No | 54.5 Percentage of Participants |
Primary
Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported.
Time frame: Baseline (stage 2), Week 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24 | 86.9 Percent change | Standard Deviation 112.33 |
Primary
Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Percent change from baseline in weekly PS volume at Week 24 was reported.
Time frame: Baseline (stage 2), Week 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | -30.07 Percent change in PS volume | Standard Deviation 25.892 |
Primary
Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24
Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Time frame: Baseline (stage 3), Extension Month 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24 | -2.1 days/week | Standard Deviation 3.34 |
Primary
Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Time frame: Baseline (stage 3), Extension Month 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | 28.3 Micromoles per liter | Standard Deviation 24.05 |
Primary
Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Time frame: Baseline (stage 3), Extension Month 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | -8.33 L/week | Standard Deviation 5.94 |
Primary
Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Time frame: Baseline (stage 3), Extension Month 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24 | 135.0 Percent change | Standard Deviation 84.17 |
Primary
Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24
Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.
Time frame: Baseline (stage 3), Extension Month 24
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24 | -53.53 Percent change in PS volume | Standard Deviation 33.866 |
Primary
Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment
Absolute change from baseline in number of days per week of PS usage at end of treatment was reported.
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Population: ITT population consists of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment | -1.4 days/week | Standard Deviation 2.8 |
Primary
Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment
Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported.
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment | 19.3 Micromoles per liter | Standard Deviation 19.96 |
Primary
Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment
Absolute change from baseline in weekly PS volume at end of treatment was reported.
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | -5.08 L/week | Standard Deviation 6.404 |
Primary
Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment
Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported.
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment | 110.3 Percent change | Standard Deviation 98.13 |
Primary
Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment
Percent change from baseline in weekly PS volume at end of treatment was reported.
Time frame: Baseline (stage 4), End of Treatment (up to 47 months)
Population: ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment | -34.12 Percent change in PS volume | Standard Deviation 38.877 |
Secondary
Apparent Clearance (CL/F) of Teduglutide in Plasma
Apparent clearance of teduglutide in plasma were evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data are considered sufficient and interpretable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Apparent Clearance (CL/F) of Teduglutide in Plasma | 14.5 liter per hour (L/h) | Standard Deviation 4.09 |
Secondary
Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma
Apparent volume of distribution of teduglutide in plasma were evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma | 27.8 liter | Standard Deviation 22.5 |
Secondary
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma
Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: Pharmacokinetic (PK) analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma | 204 Nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 51.1 |
Secondary
Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma
Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma | 201 ng*h/mL | Standard Deviation 51.6 |
Secondary
Maximum Concentration (Cmax) of Teduglutide in Plasma
Maximum concentration of teduglutide in plasma were evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teduglutide | Maximum Concentration (Cmax) of Teduglutide in Plasma | 49.7 Nanogram per milliliter (ng/mL) | Standard Deviation 19.7 |
Secondary
Terminal Half-Life (t1/2) of Teduglutide in Plasma
Terminal half-life of teduglutide in plasma were evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Teduglutide | Terminal Half-Life (t1/2) of Teduglutide in Plasma | 1.06 hour |
Secondary
Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma
Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated.
Time frame: Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose
Population: PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Teduglutide | Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma | 2.49 hour |