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A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT03713242
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: ACT-541468 25 mg Drug: ACT-541468 25 mg (or 10 mg depending on interim results) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: prospective, single-center, open-label, single-dose
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: Group A: ACT-541468 in subjects with mild hepatic impairment
Single oral dose administered on Day 1.
Drug: ACT-541468 25 mg
Administered as a tablet.

Experimental: Group B: ACT-541468 in subj. with moderate hepatic impairment
Single oral dose administered on Day 1.
Drug: ACT-541468 25 mg (or 10 mg depending on interim results)
Administered as a tablet.

Experimental: Group C: ACT-541468 in subjects with severe hepatic impairment
Single oral dose administered on Day 1.
Drug: ACT-541468 25 mg (or 10 mg depending on interim results)
Administered as a tablet.

Experimental: Group D: ACT-541468 in healthy subjects.
Single oral dose administered on Day 1.
Drug: ACT-541468 25 mg (or 10 mg depending on interim results)
Administered as a tablet.




Primary Outcome Measures :
  1. Treatment-emergent adverse events (AEs) [ Time Frame: From study treatment administration up to EOS (duration: up to 4 days) ]
  2. Treatment-emergent serious adverse events (SAEs) [ Time Frame: From study treatment administration up to EOS (duration: up to 4 days) ]

Other Outcome Measures:
  1. Plasma pharmacokinetics: AUC(0-t) [ Time Frame: At various timepoints (duration: up to 4 days) ]
  2. Plasma pharmacokinetics: AUC(0-inf) [ Time Frame: At various timepoints (duration: up to 4 days) ]
  3. Plasma pharmacokinetics: AUC(0-24) [ Time Frame: At various timepoints (duration: up to 4 days) ]
  4. Plasma pharmacokinetics: Cmax [ Time Frame: At various timepoints (duration: up to 4 days) ]
  5. Plasma pharmacokinetics: Tmax [ Time Frame: At various timepoints (duration: up to 4 days) ]
  6. Plasma pharmacokinetics: T1/2 [ Time Frame: At various timepoints (duration: up to 4 days) ]
  7. Plasma pharmacokinetics: Cu/C (extent of plasma protein binding) [ Time Frame: At various timepoints (duration: up to 4 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Male and female subjects aged between 18 and 75 years (inclusive) at screening.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
  • Women of non-childbearing potential.
  • Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
  • For healthy subjects: Normal renal function confirmed by a creatinine clearance at screening according to Cockroft and Gault adjusted to age of:

    1. ≥ 80 mL/min/1.73 m2 for subjects ≤ 50 years of age.
    2. ≥ 70 mL/min/1.73 m2 for subjects 51-60 years of age.
    3. ≥ 60 mL/min/1.73 m2 for subjects 61-75 years of age.
  • For subjects with hepatic impairment: Degree of liver function impairment due to liver cirrhosis according to the Child-Pugh classification:

    1. Group A: Mild hepatic impairment, Child-Pugh score 5-6.
    2. Group B: Moderate hepatic impairment, Child-Pugh score 7-9.
    3. Group C: Severe hepatic impairment, Child-Pugh score 10-15.

Exclusion Criteria:

  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
  • For subjects with hepatic impairment: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).
  • For healthy subjects:

    1. History of alcoholism or drug abuse within the 3-year period prior to screening.
    2. Relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.

Information from the National Library of Medicine

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): NCT03713242


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03713242     History of Changes
Obsolete Identifiers: NCT03686995
Other Study ID Numbers: ID-078-112
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases