A Study to Evaluate the Bioavailability of Teduglutide Ad... | NCT04465396

NCT04465396

Status Module

Sponsor/Collaborators Module

Name	Class
Takeda Development Center Americas, Inc.	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)	Experimental	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.	Drug: Teduglutide Device: Syringe Injection Device: Pen injector
Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)	Experimental	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.	Drug: Teduglutide Device: Syringe Injection Device: Pen injector
Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)	Experimental	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.	Drug: Teduglutide Device: Syringe Injection Device: Pen injector
Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teduglutide	Drug	Participants received 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of Treatment Periods 1 and 2.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide		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
Maximum Observed Plasma Concentration (Cmax) of Teduglutide	Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	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
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide		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

Secondary Outcomes

Measure	Description	Time Frame
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	AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Ability to voluntarily provide written, signed, and dated informed consent and assent as applicable to participate in the study.
Aged 18 - 45 inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a full physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, coagulation (as appropriate), serum chemistry, and urinalysis.
Body mass index (BMI) >= 18.0 and l<=32.0 kilogram per square meter (kg/m^2) at screening. Body weight for a participant in Cohort 1 will be >= 40.0 kg to <= 75.0 kg, and body weight for a participant in Cohort 2 will be > 75.0 kg to <= 120.0 kg, inclusive. This inclusion criterion will be assessed at the screening visit and confirmed at first check-in.

Exclusion Criteria:

History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Positive PCR (polymerase chain reaction) test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), either with the absence or presence of the clinical symptoms of Coronavirus disease 2019 (COVID-19).
Known or suspected intolerance or hypersensitivity to teduglutide, closely-related compounds, or any of the stated ingredients.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of teduglutide.
Known history of alcohol or other substance abuse within the last year prior to screening.
Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the first dose of teduglutide.
Pregnant or lactating female.
Within 30 days prior to the first dose of teduglutide:
1. Have used an investigational product (if elimination half-life is lesser than [<] 6 days, otherwise 5 half-lives)
2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's (or designee's) opinion, may impact this study
3. Have had any substantial changes in eating habits, as assessed by the investigator (or designee)
Use of dipeptidyl peptidase 4 inhibitors within 30 days or 5 half-lives, whichever is greater, prior to administration of the first dose of teduglutide.
Confirmed systolic blood pressure > 140 millimeter of mercury (mmHg) or < 90 mmHg, and diastolic blood pressure > 90 mmHg or < 40 mmHg at screening.
Twelve-lead electrocardiogram (ECG) demonstrating QTcF > 450 milliseconds (msec) at screening. If the QTcF exceeds the aforementioned limits, the ECG should be repeated 2 more times and the average of the 3 QTcF values should be used to determine the participants eligibility.
Positive screen for drugs of abuse or alcohol at screening and at each check-in.
Male participants who consume more than 21 units of alcohol per week or regularly consume more than 3 units per day. Female participants who consume more than 14 units of alcohol per week or regularly consume more than 2 units per day. (1 alcohol unit=150 milliliter [mL] of wine, or 360 mL of beer, or 45 mL of 45 percent [%] alcohol).
Positive Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen at screening.
Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch) based on participant self-reporting. Ex-users must report that they have stopped using tobacco for at least 3 months prior to receiving the first dose of teduglutide.
Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6 ounce (oz) (180 mL) cup of coffee, two 12 oz (360 mL) cans of cola, one 12 oz (360 mL) cup of tea, three 1 oz (85 gram [g]) chocolate bars.
Prior screen failure, randomization, participation, or enrollment in this study, or prior exposure to any Glucagon-like peptide 2 (GLP-2) analogs.
Presence of lesions, rashes, tattoos, and moles etc. on administration sites not allowing adequate conduct of injection site reaction and injection site injury assessment
Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of occasional use of ibuprofen [1.2 g per 24 hour period] or acetaminophen [2 g per 24 hour period]). Current use is defined as use within 14 days of the first dose of teduglutide and throughout the study.

Contacts/Locations Module

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Phoenix	Arizona	85283	United States

References Module

Label	URL
To obtain more information on the study, click here/on this link	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 9, 2020	Mar 25, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)

Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)

Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)

Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)

FG00016 subjects
FG00116 subjects
FG00216 subjects
FG00316 subjects

Safety Set included all participants who received at least one dose of the study drug.

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG00116 BG00216 BG00316 BG00464

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00031.8(20 to 41) BG00132.4(20 to 45) BG00232.5(18 to 39) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG0019 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG00114 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00016 BG00116 BG002

Height

Mean

Full Range

Title

Denominators

Categories

Title	Measurements
	BG000163.19(151.0 to 175.0) BG001164.06(151.0 to 177.0) BG002

Weight

Mean

Full Range

Title

Denominators

Categories

Title	Measurements
	BG00064.38(55.4 to 73.5) BG00166.51(55.8 to 73.4) BG002

Body Mass Index (BMI)

BMI = weight (kg)/[height (m)^2]

Mean

Full Range

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00024.271(19.31 to 30.72) BG00124.891(20.12 to 30.25)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide

Pharmacokinetic (PK) Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hour/mL

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.
OG003	Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	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.

Units	Counts
Participants	OG00032 OG00132 OG00232 OG003

Title

Denominators

Categories

Title	Measurements
	OG000217.2± 21.0 OG001237.2± 22.1 OG002221.9± 21.2 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Geometric Mean Ratio	109.22			2-Sided	90	104.83	113.80			The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.		Equivalence	Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.

Primary

Maximum Observed Plasma Concentration (Cmax) of Teduglutide

Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Primary

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Secondary

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

AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.

PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen	Teduglutide, 3 mg, SC injection using a syringe in the abdomen, 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.
OG001	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm	Teduglutide, 3 mg, SC injection using a syringe 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.
OG002	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh	Teduglutide, 3 mg, SC injection using a syringe 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.

Secondary

Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site

Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.

PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen	Teduglutide, 3 mg, SC injection using a syringe in the abdomen, 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.
OG001	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm	Teduglutide, 3 mg, SC injection using a syringe 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.
OG002	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh	Teduglutide, 3 mg, SC injection using a syringe 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.

Secondary

Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site

AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen	Teduglutide, 3 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1and 2. Participants with >=40.0 kg to <=75.0 kg of weight were included in Cohort 1.
OG001	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm	Teduglutide, 3 mg, SC injection using a syringe 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.
OG002	Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh

Secondary

Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide

PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.

Posted

Median

Full Range

hour

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.
OG003

Secondary

Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide

Posted

Geometric Mean

Geometric Coefficient of Variation

1/hr

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Secondary

Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide

Posted

Mean

Standard Deviation

hour

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Secondary

Apparent Total Body Clearance (CL/F) of Teduglutide

CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.

Posted

Mean

Standard Deviation

Liter(L)/hr

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Secondary

Apparent Volume of Distribution (Vz/F) of Teduglutide

Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Safety Set included all participants who received at least one dose of the study drug.

Posted

Count of Participants

Participants

From the start of study drug administration up to follow-up (up to 42 days)

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)

Secondary

Number of Participants With Clinically Significant Change in Vital Signs

Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.

Safety Set included all participants who received at least one dose of the study drug.

Posted

Count of Participants

Participants

From the start of study drug administration up to follow-up (up to 42 days)

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Secondary

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

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.

Safety Set included all participants who received at least one dose of the study drug.

Posted

Count of Participants

Participants

From the start of study drug administration up to follow-up (up to 42 days)

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Secondary

Number of Participants With Clinically Significant Changes in Physical Examinations

Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.

Safety Set included all participants who received at least one dose of the study drug.

Posted

Count of Participants

Participants

From the start of study drug administration up to follow-up (up to 42 days)

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection))	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.

Secondary

Number of Participants With Device Malfunction

Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.

Safety Set included all participants who received at least one dose of the study drug.

Posted

Count of Participants

Participants

Day 1

ID	Title	Description
OG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.
OG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.
OG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	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.	32	32	13	32
EG001	Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	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.	32	32	10	32
EG002	Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	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.	32	32	9	32
EG003	Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	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.	32	32	1	32

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA24.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected32 at risk EG0020 affected32 at risk EG0030 affected32 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0002 affected32 at risk EG0012 affected32 at risk EG0022 affected32 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0000 affected32 at risk EG0013 affected32 at risk EG0020 affected32 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0001 affected32 at risk EG0014 affected32 at risk EG0020 affected32 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA24.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk EG0020 affected32 at risk EG003
Injection site erythema	General disorders	MedDRA24.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk EG0022 affected32 at risk EG003
Injection site pain	General disorders	MedDRA24.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected32 at risk EG0023 affected32 at risk EG003
Vessel puncture site pain	General disorders	MedDRA24.0	Systematic Assessment	EG0001 affected32 at risk EG0012 affected32 at risk EG0020 affected32 at risk EG003
Dizziness	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected32 at risk EG0013 affected32 at risk EG0020 affected32 at risk EG003
Headache	Nervous system disorders	MedDRA24.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected32 at risk EG0022 affected32 at risk EG003

ID	Term
C494910	teduglutide
D013594	Syringes

BG003175.38(163.0 to 187.0)

BG004169.11(151 to 189)

BG00384.68(75.3 to 106.8)

BG00475.49(55.4 to 108.8)

BG00327.530(22.99 to 31.41)

BG00426.313(19.31 to 31.81)

Teduglutide, 3 mg, SC injection using a syringe 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.

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.