Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatic Impairment

Keywords

Hepatic ImpairmentLiver FunctionHepatic Function

Outcome Measures

Primary Outcomes (3)

Area Under the Curve to Infinity (AUCinf) of Apraglutide
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 time point with concentrations above the lower limit of quantification and kel was the terminal elimination rate constant.
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose
Area Under the Curve (AUC) From Time Zero to 168 Hours Post-dose (AUC0-168h) of Apraglutide
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.
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, and 168 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Apraglutide
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.

Secondary Outcomes (6)

Time of Maximum Plasma Concentration (Tmax) of Apraglutide
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose
Apparent Clearance After Extravascular Administration (CL/F) of Apraglutide
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose
Terminal Elimination Rate Constant (Kel) of Apraglutide
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose
Terminal Half-life (t1/2) of Apraglutide
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose
Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Apraglutide
Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose
+1 more secondary outcomes

Study Arms (3)

Part 1: Moderate hepatic impairment

EXPERIMENTAL

Child-Pugh B

Drug: Apraglutide

Part 1: Normal hepatic function

EXPERIMENTAL

Drug: Apraglutide

Part 2: Mild hepatic impairment

EXPERIMENTAL

Child-Pugh A

Drug: Apraglutide

Interventions

ApraglutideDrug

Single dose of apraglutide

Part 1: Moderate hepatic impairmentPart 1: Normal hepatic functionPart 2: Mild hepatic impairment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All Participants:
Age between 18 and 75 years inclusive

Sponsors & Collaborators

VectivBio AG
Industrylead

Study Sites (2)

APEX

Münich, Germany

Summit Clinical Research

Bratislava, Slovakia

MeSH Terms

Interventions

apraglutide

Limitations and Caveats

Part 2 was to be conducted if the geometric mean ratio (GMR) point estimate of apraglutide AUCinf or AUClast for the moderate hepatic impairment group compared with the control group was ≥2. As the GMR point estimate of AUCinf was \<2, the trial stopped after Part 1.

Results Point of Contact

Title: Clinical Trial Information Desk
Organization: VectivBio AG

Study Officials

Tomasz Masior
VectivBio AG
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

16 participants (actual enrollment reported by the registry).

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

January 20, 2023

First Posted

January 31, 2023

Study Start

January 30, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (3)

Part 1: Moderate hepatic impairment

Part 1: Normal hepatic function

Part 2: Mild hepatic impairment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (3)

Part 1: Moderate hepatic impairment

Part 1: Normal hepatic function

Part 2: Mild hepatic impairment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations