Healthy VolunteersPhase 1NCT04465396
A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
A Phase 1 study testing Teduglutide, Syringe Injection and Pen injector in people with Healthy Volunteers, run by Shire at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Teduglutide, Syringe Injection and Pen injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 20 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- Have used an investigational product (if elimination half-life is lesser than [<] 6 days, otherwise 5 half-lives)
- Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's (or designee's) opinion, may impact this study
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Two-treatment, Two-period, Single-dose, Crossover Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Subjects
The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants.
Read the detailed description
This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of participant's with greater than or equal to (>=) 40.0 kilogram (kg) to lesser than or equal to (<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (>) 75.0 kg to <= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2 treatment sequences AB or BA. Randomization will be stratified by injection site (i.e., thigh, abdomen, and arm) within each cohort.
- Conditions
- Healthy Volunteers
- Being tested
- Teduglutide, Syringe Injection, Pen injector
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
Also called TAK-633
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.
Syringe InjectionDevice
Teduglutide was administered using syringe.
Pen injectorDevice
Teduglutide was administered using pen injector.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Teduglutide; Device: Syringe Injection; Device: Pen injector |
| Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2) | Experimental | 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. Receives: Drug: Teduglutide; Device: Syringe Injection; Device: Pen injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide
Measured: 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.
Measured: 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
Measured: 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 (13)
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.
Measured: 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 by Injection Site
Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Measured: 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 by Injection Site
AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Measured: 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
Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide
Measured: 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
Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide
Measured: 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
Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From the start of study drug administration up to follow-up (up to 42 days)
Number of Participants With Clinically Significant Change in Vital Signs
Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.
Measured: From the start of study drug administration up to follow-up (up to 42 days)
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.
Measured: From the start of study drug administration up to follow-up (up to 42 days)
Number of Participants With Clinically Significant Changes in Physical Examinations
Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.
Measured: From the start of study drug administration up to follow-up (up to 42 days)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start13 Jan 2021
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465396
- Sponsor's protocol ID
- TAK-633-1001
- Status last verified
- Mar 2022
- First submitted
- 7 Jul 2020
- Last updated
- 4 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-treatment, Two-period, Single-dose, Crossover Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04465396
- Acronym / sponsor ID
- TAK-633-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 4 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants.
Detailed description
This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of participant's with greater than or equal to (>=) 40.0 kilogram (kg) to lesser than or equal to (<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (>) 75.0 kg to <= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2 treatment sequences AB or BA. Randomization will be stratified by injection site (i.e., thigh, abdomen, and arm) within each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1) | Experimental | Drug: Teduglutide, Device: Syringe Injection, Device: Pen injectorTeduglutide, 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) | Experimental | Drug: Teduglutide, Device: Syringe Injection, Device: Pen injectorTeduglutide, 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) | Experimental | Drug: Teduglutide, Device: Syringe Injection, Device: Pen injectorTeduglutide, 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) | Experimental | Drug: Teduglutide, Device: Syringe Injection, Device: Pen injectorTeduglutide, 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeduglutideAlso: TAK-633Participants 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. | Drug | 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) |
| Syringe InjectionTeduglutide was administered using syringe. | Device | 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) |
| Pen injectorTeduglutide was administered using pen injector. | Device | 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) |
Primary outcome
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide
Time frame: 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
Time frame: 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
Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide
Time frame: 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
13 secondary outcomes
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
Time frame: 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 by Injection Site
Time frame: 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 by Injection Site
Time frame: 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
Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide
Time frame: 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
Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide
Time frame: 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
Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide
Time frame: 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
Apparent Total Body Clearance (CL/F) of Teduglutide
Time frame: 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
Apparent Volume of Distribution (Vz/F) of Teduglutide
Time frame: 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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the start of study drug administration up to follow-up (up to 42 days)
Number of Participants With Clinically Significant Change in Vital Signs
Time frame: From the start of study drug administration up to follow-up (up to 42 days)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: From the start of study drug administration up to follow-up (up to 42 days)
Number of Participants With Clinically Significant Changes in Physical Examinations
Time frame: From the start of study drug administration up to follow-up (up to 42 days)
Number of Participants With Device Malfunction
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teduglutide, Syringe Injection and Pen injector in people with Healthy Volunteers, run by Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.