A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: Teduglutide; Syringe Injection; Pen injector
Intervention description: 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.; Teduglutide was administered using syringe.; Teduglutide was administered using pen injector.
Intervention MeSH terms: Teduglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

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.
    

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.