Trial Outcomes & Findings for A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants (NCT NCT04465396)
NCT ID: NCT04465396
Last Updated: 2022-10-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Results posted on
2022-10-04
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 13 January 2021 to 20 August 2021.
Healthy participants were enrolled in 1 of the 2 cohorts of this 2-period cross-over study to receive teduglutide (TAK-633) 3 or 4 milligrams (mg), subcutaneously by syringe injection (Treatment A1 for Cohort 1 and Treatment A2 for Cohort 2) or through pen injector (Treatment B1 for Cohort 1 and Treatment B2 for Cohort 2). Randomization was stratified by injection site (thigh, abdomen, and arm) within each cohort .
Participant milestones
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|
|
Treatment Period 1 (Day 1)
STARTED
|
16
|
16
|
16
|
16
|
|
Treatment Period 1 (Day 1)
COMPLETED
|
16
|
16
|
16
|
16
|
|
Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (7 Days)
STARTED
|
16
|
16
|
16
|
16
|
|
Washout Period (7 Days)
COMPLETED
|
16
|
16
|
16
|
16
|
|
Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 1)
STARTED
|
16
|
16
|
16
|
16
|
|
Treatment Period 2 (Day 1)
COMPLETED
|
16
|
15
|
15
|
16
|
|
Treatment Period 2 (Day 1)
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|
|
Treatment Period 2 (Day 1)
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
n=16 Participants
Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1
|
Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
n=16 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
n=16 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
n=16 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.8 years
n=5 Participants
|
32.4 years
n=7 Participants
|
32.5 years
n=5 Participants
|
35.9 years
n=4 Participants
|
33.2 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Height
|
163.19 cm
n=5 Participants
|
164.06 cm
n=7 Participants
|
173.81 cm
n=5 Participants
|
175.38 cm
n=4 Participants
|
169.11 cm
n=21 Participants
|
|
Weight
|
64.38 kg
n=5 Participants
|
66.51 kg
n=7 Participants
|
86.39 kg
n=5 Participants
|
84.68 kg
n=4 Participants
|
75.49 kg
n=21 Participants
|
|
Body Mass Index (BMI)
|
24.271 kg/m^2
n=5 Participants
|
24.891 kg/m^2
n=7 Participants
|
28.558 kg/m^2
n=5 Participants
|
27.530 kg/m^2
n=4 Participants
|
26.313 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: Pharmacokinetic (PK) Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide
|
217.2 ng*hour/mL
Geometric Coefficient of Variation 21.0
|
237.2 ng*hour/mL
Geometric Coefficient of Variation 22.1
|
221.9 ng*hour/mL
Geometric Coefficient of Variation 21.2
|
253.0 ng*hour/mL
Geometric Coefficient of Variation 21.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.
Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Teduglutide
|
33.90 ng/mL
Geometric Coefficient of Variation 37.7
|
33.31 ng/mL
Geometric Coefficient of Variation 37.6
|
31.99 ng/mL
Geometric Coefficient of Variation 34.8
|
29.58 ng/mL
Geometric Coefficient of Variation 32.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=30 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=30 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=30 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=30 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide
|
227.6 ng*hr/mL
Geometric Coefficient of Variation 21.1
|
249.2 ng*hr/mL
Geometric Coefficient of Variation 20.8
|
227.1 ng*hr/mL
Geometric Coefficient of Variation 20.8
|
268.2 ng*hr/mL
Geometric Coefficient of Variation 22.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.
AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=12 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=10 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=10 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=12 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
n=10 Participants
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
n=10 Participants
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
n=12 Participants
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
n=10 Participants
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
n=10 Participants
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
n=12 Participants
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
n=10 Participants
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
n=10 Participants
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide by Injection Site
|
241.2 ng*hr/mL
Geometric Coefficient of Variation 14.0
|
205.8 ng*hr/mL
Geometric Coefficient of Variation 29.1
|
202.2 ng*hr/mL
Geometric Coefficient of Variation 14.4
|
277.6 ng*hr/mL
Geometric Coefficient of Variation 9.1
|
216.6 ng*hr/mL
Geometric Coefficient of Variation 27.8
|
215.2 ng*hr/mL
Geometric Coefficient of Variation 16.7
|
219.6 ng*hr/mL
Geometric Coefficient of Variation 17.2
|
222.6 ng*hr/mL
Geometric Coefficient of Variation 27.9
|
224.1 ng*hr/mL
Geometric Coefficient of Variation 20.3
|
239.5 ng*hr/mL
Geometric Coefficient of Variation 19.0
|
277.3 ng*hr/mL
Geometric Coefficient of Variation 23.3
|
246.4 ng*hr/mL
Geometric Coefficient of Variation 21.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.
Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=12 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=10 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=10 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=12 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
n=10 Participants
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
n=10 Participants
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
n=12 Participants
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
n=10 Participants
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
n=10 Participants
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
n=12 Participants
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
n=10 Participants
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
n=10 Participants
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site
|
40.84 ng/mL
Geometric Coefficient of Variation 29.7
|
31.66 ng/mL
Geometric Coefficient of Variation 41.6
|
29.02 ng/mL
Geometric Coefficient of Variation 35.2
|
43.65 ng/mL
Geometric Coefficient of Variation 20.7
|
28.73 ng/mL
Geometric Coefficient of Variation 43.9
|
27.91 ng/mL
Geometric Coefficient of Variation 27.3
|
26.86 ng/mL
Geometric Coefficient of Variation 25.9
|
38.28 ng/mL
Geometric Coefficient of Variation 43.8
|
32.97 ng/mL
Geometric Coefficient of Variation 25.0
|
28.14 ng/mL
Geometric Coefficient of Variation 30.4
|
32.33 ng/mL
Geometric Coefficient of Variation 33.8
|
28.73 ng/mL
Geometric Coefficient of Variation 35.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.
AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=12 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=9 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=9 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=12 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
n=9 Participants
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
n=9 Participants
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
n=12 Participants
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
n=9 Participants
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
n=9 Participants
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
n=12 Participants
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
n=9 Participants
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
n=9 Participants
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site
|
246.6 ng*hr/mL
Geometric Coefficient of Variation 13.2
|
213.0 ng*hr/mL
Geometric Coefficient of Variation 29.5
|
218.6 ng*hr/mL
Geometric Coefficient of Variation 18.7
|
282.3 ng*hr/mL
Geometric Coefficient of Variation 9.1
|
229.6 ng*hr/mL
Geometric Coefficient of Variation 26.8
|
229.2 ng*hr/mL
Geometric Coefficient of Variation 18.6
|
224.7 ng*hr/mL
Geometric Coefficient of Variation 17.6
|
228.2 ng*hr/mL
Geometric Coefficient of Variation 27.1
|
228.7 ng*hr/mL
Geometric Coefficient of Variation 20.0
|
247.0 ng*hr/mL
Geometric Coefficient of Variation 19.7
|
296.8 ng*hr/mL
Geometric Coefficient of Variation 24.4
|
268.1 ng*hr/mL
Geometric Coefficient of Variation 20.9
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide
|
4.002 hour
Interval 2.0 to 8.06
|
4.001 hour
Interval 0.5 to 8.05
|
4.999 hour
Interval 2.01 to 8.04
|
4.507 hour
Interval 2.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=30 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=30 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=30 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=30 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide
|
0.4055 1/hr
Geometric Coefficient of Variation 51.2
|
0.4191 1/hr
Geometric Coefficient of Variation 41.0
|
0.3971 1/hr
Geometric Coefficient of Variation 41.8
|
0.3236 1/hr
Geometric Coefficient of Variation 48.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=30 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=30 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=30 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=30 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide
|
1.930 hour
Standard Deviation 1.1070
|
1.797 hour
Standard Deviation 0.8341
|
1.903 hour
Standard Deviation 0.9107
|
2.385 hour
Standard Deviation 1.2292
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.
CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=30 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=30 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=30 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=30 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Teduglutide
|
13.48 Liter(L)/hr
Standard Deviation 3.2060
|
12.31 Liter(L)/hr
Standard Deviation 2.9332
|
17.97 Liter(L)/hr
Standard Deviation 3.5737
|
15.27 Liter(L)/hr
Standard Deviation 3.5042
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2Population: PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.
Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=30 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=30 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=30 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=30 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Teduglutide
|
36.85 L
Standard Deviation 18.837
|
31.86 L
Standard Deviation 15.382
|
49.84 L
Standard Deviation 27.394
|
51.01 L
Standard Deviation 23.867
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of study drug administration up to follow-up (up to 42 days)Population: Safety Set included all participants who received at least one dose of the study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. Number of participants with TEAEs included injection site reactions and injection site injury assessments.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
13 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of study drug administration up to follow-up (up to 42 days)Population: Safety Set included all participants who received at least one dose of the study drug.
Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of study drug administration up to follow-up (up to 42 days)Population: Safety Set included all participants who received at least one dose of the study drug.
Clinical laboratory assessments included hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of study drug administration up to follow-up (up to 42 days)Population: Safety Set included all participants who received at least one dose of the study drug.
Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety Set included all participants who received at least one dose of the study drug.
Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.
Outcome measures
| Measure |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 Participants
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 Participants
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 Participants
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 Participants
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm
Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh
Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen
Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm
Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh
Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen
Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm
Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh
Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Device Malfunction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
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 |
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)
n=32 participants at risk
Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)
n=32 participants at risk
Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with \>=40.0 kg to \<=75.0 kg of weight were included in Cohort 1.
|
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)
n=32 participants at risk
Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)
n=32 participants at risk
Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants \>75.0 kg to \<=120.0 kg of weight were included in Cohort 2.
|
|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
9.4%
3/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
12.5%
4/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
General disorders
Injection site erythema
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
3.1%
1/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
General disorders
Injection site pain
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
3.1%
1/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
9.4%
3/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
3.1%
1/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
General disorders
Vessel puncture site pain
|
3.1%
1/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
9.4%
3/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
6.2%
2/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
0.00%
0/32 • From the start of study drug administration up to follow-up (up to 42 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place