Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.

NCT04699032 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TA799-014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.

Conditions

Chronic Kidney Disease

Keywords

Renal Function; Renal Impairment; Kidney Function

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of Apraglutide

  Pharmacokinetic (PK) samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.

  5 minutes pre-dose up to 240 hours after dosing on Day 1

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide

  PK samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.

  5 minutes pre-dose up to 240 hours after dosing on Day 1

Secondary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Day 1 up to Day 14

• Number of TEAEs

  Day 1 up to Day 14

Study Arms (4)

Severe Renal Impairment

EXPERIMENTAL

eGFR (mL/min/1.73 m2): \<30 not on hemodialysis

Drug: Apraglutide

Normal Healthy Match

EXPERIMENTAL

eGFR (mL/min/1.73 m2): ≥90

Drug: Apraglutide

Moderate Renal Impairment

EXPERIMENTAL

eGFR (mL/min/1.73 m2): ≥30 to 60

Drug: Apraglutide

Mild Renal Impairment

EXPERIMENTAL

eGFR (mL/min/1.73 m2): ≥60 to 90

Drug: Apraglutide

Interventions

Apraglutide DRUG

Single dose of apraglutide 5 mg.

Mild Renal Impairment; Moderate Renal Impairment; Normal Healthy Match; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥17.5 to ≤40 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.
• Healthy participants
• No clinically relevant abnormalities (medical history, vital signs, ECG, safety labs)
• eGFR measured by CKD-EPI ≥90 mL/min/1.73 m2) at two screening visits
• Demographically comparable to the group of subjects with impaired renal function:
• Participants with impaired renal function
• Severe renal impairment: eGFR \<30 mL/min/1.73 m2, but not requiring hemodialysis
• Moderate renal impairment: eGFR ≥30 mL/min/1.73 m2 and \<60 mL/min/1.73 m2
• Mild renal impairment: eGFR ≥60 and \<90 mL/min/1.73 m2

You may not qualify if:

• All Subjects
• Renal transplant recipients
• History of systemic infection
• Any active malignancies or history of malignancies within the past 2 years
• Acute or chronic medical or psychiatric condition
• Treatment with an IMP within 30 days or 5 half-lives (whichever is longer) preceding the dose of IMP
• Male subjects partners of WOCBP who are unable to comply with the contraceptive measures
• History of clinically significant intestinal adhesions and/or chronic abdominal pain
• History of known colon polyps or family history of familial adenomatous polyposis
• Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV)-1 and -2 antibodies
• Serum albumin concentration \<25 g/L (2.5 g/dL)
• Hemoglobin concentration \<90 g/L (9.0 g/dL)
• Aspartate amino transaminase (AST) or alanine amino transaminase (ALT) values \>2 × upper limit of normal (ULN)
• Proteinuria of \>3 g total bilirubin \>1.5 × ULN
• Positive urine test for alcohol or illicit drugs at either Screening or admission.

Sponsors & Collaborators

• VectivBio AG: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Prism Clinical Research, Inc.

Saint Paul, Minnesota, 55114, United States

Location

Related Publications (1)

• Greig G, Youssef NN, Bolognani F. Pharmacokinetics and Tolerability of a Single Dose of Apraglutide, a Novel, Long-Acting, Synthetic glucagon-like peptide-2 Analog With a Unique Pharmacologic Profile, in Individuals With Impaired Renal Function. J Clin Pharmacol. 2024 Jun;64(6):744-754. doi: 10.1002/jcph.2423. Epub 2024 Mar 11.

  PMID: 38465515 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

apraglutide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Reda Sheik
• Organization: VectivBio AG

clinicaltrials@vectivbio.com

+41615513030

Study Officials

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 7, 2021
• Study Start: December 8, 2020
• Primary Completion: July 5, 2021
• Study Completion: July 5, 2021
• Last Updated: October 26, 2024
• Results First Posted: May 15, 2023

Record last verified: 2022-07

Locations

US (2)