NCT05706623

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

Completed Phase 1 Results posted Last updated 10 July 2025

What this trial tests

Phase 1 trial testing Apraglutide in Hepatic Impairment in 16 participants. Completed in 4 April 2023.

Timeline

30 January 2023

Primary endpoint
4 April 2023

4 April 2023

Quick facts

Lead sponsor	VectivBio AG
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	30 January 2023
Primary completion	4 April 2023
Estimated completion	4 April 2023
Sites	2 locations across Slovakia, Germany

Drugs / interventions tested

• Apraglutide — full drug profile →

Conditions studied

• Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

VectivBio AG — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. 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 Curve to Infinity (AUCinf) of Apraglutide Primary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a lower limit of quantification (LLOQ) of 1 ng/mL and an upper limit of 200 ng/mL. Plasma pharmacokinetic (PK) parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used. AUCinf was calculated as: AUCinf = AUC from time zero to the last quantifiable concentration (AUClast) + (Clast/kel) where Clast was the observed concentration at the last

Group	Value	95% CI
Normal Hepatic Function Group	4481	± 64.5
Moderate Hepatic Impairment Group	3744	± 50.2

Area Under the Curve (AUC) From Time Zero to 168 Hours Post-dose (AUC0-168h) of Apraglutide Primary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, and 168 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used.

Group	Value	95% CI
Normal Hepatic Function Group	4271	± 65.2
Moderate Hepatic Impairment Group	3605	± 50.2

Maximum Observed Plasma Concentration (Cmax) of Apraglutide Primary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used. Cmax was the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.

Group	Value	95% CI
Normal Hepatic Function Group	58.3	± 68.3
Moderate Hepatic Impairment Group	54.6	± 43.1

Time of Maximum Plasma Concentration (Tmax) of Apraglutide Secondary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used. Tmax was the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.

Group	Value	95% CI
Normal Hepatic Function Group	32.03	27.97 – 48.15
Moderate Hepatic Impairment Group	31.76	12.00 – 36.00

Apparent Clearance After Extravascular Administration (CL/F) of Apraglutide Secondary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used.

Group	Value	95% CI
Normal Hepatic Function Group	1.12	± 64.5
Moderate Hepatic Impairment Group	1.34	± 50.2

Terminal Elimination Rate Constant (Kel) of Apraglutide Secondary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used. Terminal elimination rate constant calculated by linear regression of the terminal log-linear portion of the concentration vs. time curve. Linear regression of at least three points and an adjusted r\^2 greater than or eq

Group	Value	95% CI
Normal Hepatic Function Group	0.0209	± 51.6
Moderate Hepatic Impairment Group	0.0237	± 44.4

Terminal Half-life (t1/2) of Apraglutide Secondary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used.

Group	Value	95% CI
Normal Hepatic Function Group	33.2	± 51.6
Moderate Hepatic Impairment Group	29.2	± 44.4

Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Apraglutide Secondary · Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used.

Group	Value	95% CI
Normal Hepatic Function Group	53.4	± 91.1
Moderate Hepatic Impairment Group	56.2	± 69.4

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Secondary · Day 1 to Day 14

A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were graded for severity based on the National Cancer Institute-Common Terminology Criteria for Adverse Ev

At least one TEAE

Group	Value	95% CI
Normal Hepatic Function Group	0
Moderate Hepatic Impairment Group	1

At least one serious TEAE

Group	Value	95% CI
Normal Hepatic Function Group	0
Moderate Hepatic Impairment Group	0

At least one TEAE leading to discontinuation

Group	Value	95% CI
Normal Hepatic Function Group	0
Moderate Hepatic Impairment Group	0

Any mild TEAE

Group	Value	95% CI
Normal Hepatic Function Group	0
Moderate Hepatic Impairment Group	1

Any moderate TEAE

Group	Value	95% CI
Normal Hepatic Function Group	0
Moderate Hepatic Impairment Group	1

Any related TEAE

Group	Value	95% CI
Normal Hepatic Function Group	0
Moderate Hepatic Impairment Group	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 14. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Normal Hepatic Function Group

Serious: 0/8 (0%)

Deaths: 0/8

Moderate Hepatic Impairment Group

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (2 terms — click to expand)

Reaction	System	Normal Hepatic Function Gr…	Moderate Hepatic Impairmen…
Headache	Nervous system disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT05706623 adverse events section.

Sponsor's own description

The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose administration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial.
   Greig G, Hay J, Valencia P, Boules M, et al · · 2026 · PMID 41545784 · DOI 10.1002/cpdd.70006