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COMPLETEDPHASE1

Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan

An Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on the Steady State Pharmacokinetics of Bosentan in Healthy Subjects Under Fasting Conditions

NCT04991207•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

the purpose of this study is: * To assess the effect of BIA 5 1058 400 mg on the PK of bosentan. * To assess the effect of bosentan on the PK of BIA 5 1058

Detailed Description

This study was an open label, three period, fixed sequence study in healthy male and female subjects performed at a single study center. The study comprised: * Screening during Days -28 to -2 (both inclusive). * Three treatment periods separated by a washout period of at least 10 days. Duration of Treatment: The duration of participation for each subject was approximately 2 months and 3 weeks (including the screening period).

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who met the following criteria were considered eligible to participate/continue in the study:
•Provided signed and dated informed consent before any study specific procedures were conducted.
•Male and female subjects aged 18 to 45 years (both inclusive) at the Screening Visit.
•Healthy as determined by the Principal Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12 lead electrocardiogram (ECG). If a vital sign or ECG assessment was outside of the reference range at the Screening Visit or baseline, the assessment could have been repeated once as soon as possible and in any cases before enrollment to rule out any error.
•Non-smoker or ex-smoker for at least 3 months prior to the Screening Visit.
•Body mass index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive) at the Screening Visit and on admission to each treatment period.
•Negative test results for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti HBc), immunoglobulin M (IgM) anti-HBc, hepatitis C virus antibody (anti HCV) and human immunodeficiency virus (HIV) (Types 1 and 2) antibodies at the Screening Visit.
•Negative screen for alcohol and drugs of abuse at the Screening Visit and on admission to each treatment period.
•Subject had to be willing and able to be confined to the clinical unit and had to adhere to the study and lifestyle restrictions.
•Male subjects had to use together with his female partner/spouse a highly effective contraception form of birth control in combination with a barrier method throughout the clinical study period. And agreed not to father a child or to donate sperm starting at the Screening Visit and throughout the clinical study.
+1 more criteria

Exclusion Criteria

•1. Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue disease or disorders within 5 years before the first IMP administration.
•2. Documented coronary artery disease (any of prior myocardial infarction, positive stress test, positive nuclear perfusion study, prior coronary artery bypass graft \[CABG\] surgery or percutaneous coronary intervention, angiogram showing at least 75% stenosis in a major coronary artery), acute coronary syndrome or current symptoms of myocardial ischemia and angina.
•3. Clinically relevant surgical history involving the stomach and/or intestinal system, potentially affecting absorption of IMPs.
•4. Any clinically relevant findings in the laboratory tests, particularly any abnormality in the coagulation tests or the liver function tests, as judged by the Principal Investigator, at the Screening Visit and on admission to each treatment period. If a laboratory assessment was outside of the reference range at the local laboratory at the Screening Visit or baseline, the assessment could have been repeated once as soon as possible and in any cases before enrollment to rule out laboratory error.
•5. Subjects with alanine aminotransferase (ALT) \> 1.0 x the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) \> 1.0 x ULN and/or total bilirubin \> 1.0 x ULN (isolated bilirubin \> 1.0 x ULN and 1.5 x ULN was acceptable if bilirubin was fractionated and direct bilirubin \< 35%), as confirmed by subsequent repeat assessment, at the Screening Visit and on admission to each treatment period.
•6. History of relevant atopy or drug hypersensitivity.
•7. History of alcoholism or drug abuse.
•8. History of drinking \> 24 g (males) and \> 12 g (females) of pure alcohol per day (10 g pure alcohol = 250 mL of beer \[5%\] or 35 mL of spirits \[35%\] or 100 mL of wine \[12%\]) within 3 months before first admission to the clinical unit.
•9. Use of alcohol within 72 hours before the Screening Visit and from 48 hours before dosing until completion of the Follow-up Visit.
•10. Significant infection or known inflammatory process at the Screening Visit or upon admission to all treatment periods, as judged by the Principal Investigator.
+25 more criteria

Locations (1)

PAREXEL International - Early Phase Clinical Unit - Berlin

Berlin, Germany

Key Dates

Start Date

February 6, 2018

Primary Completion Date

May 14, 2018

Completion Date

May 14, 2018

Last Updated

August 5, 2021

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

BIA 5-1058

DRUG

bosentan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

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