A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
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ClinicalTrials.gov Identifier: NCT05706623 |
Recruitment Status :
Completed
First Posted : January 31, 2023
Last Update Posted : August 16, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatic Impairment | Drug: Apraglutide | Phase 1 |
A two stage design, open label, multi-center, non-randomized trial to evaluate the the safety and tolerability of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of hepatic function. The hepatic function will estimated with the Child-Pugh classification.
Part 1: 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects with normal hepatic function (Cohort 2).
Part 2: 8 subjects with mild hepatic impairment (Cohort 3) and 8 subjects with normal hepatic function (from Cohort 2 where possible and additional subject). Part 2 will be conducted only if the geometric mean ratio (GMR) of AUCinf or AUClast for the moderate hepatic impairment group compared to the control group is ≥2.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function |
Actual Study Start Date : | January 30, 2023 |
Actual Primary Completion Date : | April 4, 2023 |
Actual Study Completion Date : | April 4, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Moderate hepatic impairment
Child-Pugh B
|
Drug: Apraglutide
Single dose of apraglutide 5mg. |
Experimental: Normal hepatic function |
Drug: Apraglutide
Single dose of apraglutide 5mg. |
Experimental: Mild hepatic impairment
Child-Pugh A
|
Drug: Apraglutide
Single dose of apraglutide 5mg. |
- Plasma apraglutide primary PK parameter: AUCinf or AUClast [ Time Frame: 0 to 312 hours ]Area under the curve to infinity (AUCinf) or area under the curve from time zero to the last quantifiable concentration (AUClast) if AUCinf cannot be reliably estimated
- Plasma apraglutide primary PK parameter: AUC0-168h [ Time Frame: 0 to 168 hours ]Area under the curve from time zero to 168 hours after apraglutide administration (AUC0-168h)
- Maximum observed plasma concentration (Cmax) [ Time Frame: 0 to 168 hours ]
- Time of maximum plasma concentration (tmax) [ Time Frame: 0 to 168 hours ]
- Apparent clearance after extravascular administration (CL/F) [ Time Frame: 0 to 168 hours ]
- Apparent volume of distribution after extravascular administration (Vz/F) [ Time Frame: 0 to 168 hours ]
- Terminal elimination rate constant (λz) [ Time Frame: 0 to 168 hours ]
- Terminal half-life (t½) [ Time Frame: 0 to 168 hours ]
- Incidence, nature,and severity of adverse events (AE) with apraglutide [ Time Frame: Baseline to Day 16 ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All Participants:
- Age between 18 and 75 years inclusive
- Subjects who are willing and able to comply with the study procedures
- Subjects able to understand and willing to sign the informed consent
- Body mass index (BMI) of ≥18 to ≤35 kg/m2; and a total body weight of >50 kg (110 lb).
- Women of childbearing potential (WOCBP) on highly effective method of contraception during the trial and for 1 month after the end of trial (EOT) visit. Sterilized or infertile or postmenopausal females.
- Male subjects with a female partner of childbearing potential: highly effective methods of contraception and no sperm donation during the trial and for 1 month after (EOT) visit.
Participants with impaired hepatic function:
- Confirmed and documented diagnosis of cirrhosis
- Moderate liver disease (Child-Pugh B): clinically stable for at least 1 month prior to screening
- Mild liver disease (Child-Pugh A): clinically stable for at least 1 month prior to screening
Exclusion Criteria:
- History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease
- Known hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same class
- If capable of reproduction, unwilling to use an effective form of contraception
- If a female of child-bearing potential, a positive urine/blood pregnancy test
- Breast-feeding women
- Positive urine/blood test for alcohol and drugs of abuse at Screening and on Day-1
- Use of prohibited medications or herbal remedies
- Known presence or history of intestinal polyps
- Known presence or history of any type of cancer
- Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0×upper limit of normal range)
- Participation in an investigational drug or device study within 30 days prior to Screening
- Donation of blood over 500 mL within 2 months prior to Screening
- Heavy use of tobacco products (i.e., smokes more than 10 cigarettes per day)
- Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
- Any intercurrent clinically significant illness in the previous 28 days before Day 1 of this study
- Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV), hepatitis B surface antigen (HBsAgB), or hepatitis C virus (HCV)
- Unwillingness or inability to comply with the study protocol for any other reason
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05706623
Germany | |
APEX | |
Münich, Germany | |
Slovakia | |
Summit Clinical Research | |
Bratislava, Slovakia |
Study Director: | Bolognani | VectivBio AG |
Responsible Party: | VectivBio AG |
ClinicalTrials.gov Identifier: | NCT05706623 |
Other Study ID Numbers: |
TA799-015 |
First Posted: | January 31, 2023 Key Record Dates |
Last Update Posted: | August 16, 2023 |
Last Verified: | July 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatic Impairment Liver Function Hepatic Function |
Liver Diseases Digestive System Diseases |