A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants

NCT04465396 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: TAK-633-1001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• 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 (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

  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

  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

  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

  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

  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

Study Arms (4)

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)

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.

Drug: Teduglutide; Device: Syringe Injection; Device: Pen injector

Interventions

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.

Also known as: TAK-633

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 Injection DEVICE

Teduglutide was administered using syringe.

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 injector DEVICE

Teduglutide was administered using pen injector.

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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Shire: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (1)

Celerion

Phoenix, Arizona, 85283, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

teduglutide; Syringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Study Director
• Organization: Takeda

ClinicalTransparency@takeda.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: January 13, 2021
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)