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Phase 1 Completed N=64 Randomized Treatment

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

Healthy Volunteers
Source: ClinicalTrials.gov NCT04465396 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide — 217.2; 237.2; 221.9; 253.0 ng*hour/mL

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide
217.2; 237.2; 221.9; 253.0
PRIMARY
Maximum Observed Plasma Concentration (Cmax) of Teduglutide
33.90; 33.31; 31.99; 29.58
PRIMARY
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide
227.6; 249.2; 227.1; 268.2
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
241.2; 205.8; 202.2; 277.6; 216.6; 215.2
SECONDARY
Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site
40.84; 31.66; 29.02; 43.65; 28.73; 27.91
SECONDARY
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site
246.6; 213.0; 218.6; 282.3; 229.6; 229.2
SECONDARY
Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide
4.002; 4.001; 4.999; 4.507
SECONDARY
Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide
0.4055; 0.4191; 0.3971; 0.3236
SECONDARY
Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide
1.930; 1.797; 1.903; 2.385
SECONDARY
Apparent Total Body Clearance (CL/F) of Teduglutide
13.48; 12.31; 17.97; 15.27
SECONDARY
Apparent Volume of Distribution (Vz/F) of Teduglutide
36.85; 31.86; 49.84; 51.01
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
13; 10; 9; 5
SECONDARY
Number of Participants With Clinically Significant Change in Vital Signs
0; 0; 0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
0; 0; 0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Physical Examinations
0; 0; 0; 0
SECONDARY
Number of Participants With Device Malfunction
0; 0; 0; 0

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 = 40.0 kg to 75.0 kg to 140 millimeter of mercury (mmHg) or 90 mmHg or 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04465396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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