NCT04465396 is a Phase 1 clinical trial of Teduglutide in Healthy Volunteers, sponsored by Shire.

Who is sponsoring NCT04465396?

NCT04465396 is sponsored by Shire.

What drugs are being tested in NCT04465396?

Interventions in NCT04465396: Teduglutide, Syringe Injection, Pen injector.

What condition does NCT04465396 study?

NCT04465396 studies Healthy Volunteers.

Is NCT04465396 still recruiting?

NCT04465396 is currently completed. Last updated 4 October 2022.

Are results published for NCT04465396?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-10-04 · How we verify

NCT04465396

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 4 October 2022

What this trial tests

Phase 1 trial testing Teduglutide in Healthy Volunteers in 64 participants. Completed in 20 August 2021.

Timeline

13 January 2021

Primary endpoint
20 August 2021

20 August 2021

Quick facts

Lead sponsor	Shire
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	13 January 2021
Primary completion	20 August 2021
Estimated completion	20 August 2021
Sites	1 location across United States

Drugs / interventions tested

Teduglutide (TEDUGLUTIDE) — full drug profile →
Syringe Injection
Pen injector

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	217.2	± 21.0
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	237.2	± 22.1
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	221.9	± 21.2
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	253.0	± 21.4

Maximum Observed Plasma Concentration (Cmax) of Teduglutide Primary · 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.

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	33.90	± 37.7
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	33.31	± 37.6
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	31.99	± 34.8
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	29.58	± 32.6

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	227.6	± 21.1
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	249.2	± 20.8
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	227.1	± 20.8
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	268.2	± 22.2

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 Secondary · 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

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen	241.2	± 14.0
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm	205.8	± 29.1
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh	202.2	± 14.4
Cohort 1 (Teduglutide 3 mg): Pen Injector in Abdomen	277.6	± 9.1
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm	216.6	± 27.8
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh	215.2	± 16.7
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen	219.6	± 17.2
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm	222.6	± 27.9
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh	224.1	± 20.3
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen	239.5	± 19.0
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm	277.3	± 23.3
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh	246.4	± 21.3

Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site Secondary · 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 of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen	40.84	± 29.7
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm	31.66	± 41.6
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh	29.02	± 35.2
Cohort 1 (Teduglutide 3 mg): Pen Injector in Abdomen	43.65	± 20.7
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm	28.73	± 43.9
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh	27.91	± 27.3
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen	26.86	± 25.9
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm	38.28	± 43.8
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh	32.97	± 25.0
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen	28.14	± 30.4
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm	32.33	± 33.8
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh	28.73	± 35.5

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

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen	246.6	± 13.2
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm	213.0	± 29.5
Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh	218.6	± 18.7
Cohort 1 (Teduglutide 3 mg): Pen Injector in Abdomen	282.3	± 9.1
Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm	229.6	± 26.8
Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh	229.2	± 18.6
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen	224.7	± 17.6
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm	228.2	± 27.1
Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh	228.7	± 20.0
Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen	247.0	± 19.7
Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm	296.8	± 24.4
Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh	268.1	± 20.9

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	4.002	2.00 – 8.06
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	4.001	0.50 – 8.05
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	4.999	2.01 – 8.04
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	4.507	2.00 – 12.00

Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide Secondary · 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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	0.4055	± 51.2
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	0.4191	± 41.0
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	0.3971	± 41.8
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	0.3236	± 48.1

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	1.930	± 1.1070
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	1.797	± 0.8341
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	1.903	± 0.9107
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	2.385	± 1.2292

Apparent Total Body Clearance (CL/F) of Teduglutide Secondary · 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

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	13.48	± 3.2060
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	12.31	± 2.9332
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	17.97	± 3.5737
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	15.27	± 3.5042

Apparent Volume of Distribution (Vz/F) of Teduglutide Secondary · 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

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

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	36.85	± 18.837
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	31.86	± 15.382
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	49.84	± 27.394
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	51.01	± 23.867

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · From the start of study drug administration up to follow-up (up to 42 days)

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.

Group	Value	95% CI
Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)	13
Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)	10
Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)	9
Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)	5

Adverse events — posted to ClinicalTrials.gov

Time frame: From the start of study drug administration up to follow-up (up to 42 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)

Serious: 0/32 (0%)

Deaths: 0/32

Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)

Serious: 0/32 (0%)

Deaths: 0/32

Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)

Serious: 0/32 (0%)

Deaths: 0/32

Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (10 terms — click to expand)

Reaction	System	Cohort 1 (Teduglutide 3 mg…	Cohort 1 (Teduglutide 3 mg…	Cohort 2 (Teduglutide 4 mg…	Cohort 2 (Teduglutide 4 mg…
Nausea	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Injection site erythema	General disorders	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04465396 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04465396 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 4 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04465396.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04465396

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Teduglutide

Other recruiting trials for Healthy Volunteers

Other Shire trials

Verify against primary sources