CompletedPhase 1

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

Germany20 participantsStarted 2018-03-22

Plain-language summary

The purpose of this study is: * To assess the effect of BIA 5 1058 400 mg on the pharmacokinetics (PK) of sildenafil. * To assess the effect of sildenafil on the PK of BIA 5-1058.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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) antibody to anti-HBc (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.
. The subject had to be willing and able to be confined to the clinical unit and had to adhere to the study and lifestyle restrictions.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax - Maximum observed concentration (for BIA 5-1058)

Timeframe: Up to 2 months and 3 weeks

Tmax - Time corresponding to occurrence of Cmax (for BIA 5-1058)

Timeframe: Up to 2 months and 3 weeks

T½ - Apparent terminal elimination half life (for BIA 5-1058)

Timeframe: Up to 2 months and 3 weeks

Cmax,ss - Maximum observed concentration at steady state (for sildenafi)

Timeframe: Up to 2 months and 3 weeks

Tmax,ss - Time corresponding to occurrence of Cmax,ss at steady state (for sildenafi)

Timeframe: Up to 2 months and 3 weeks

T½,ss - Apparent terminal elimination half-life at steady state (for sildenafi)

Timeframe: Up to 2 months and 3 weeks

Trial details

NCT IDNCT04994860

SponsorBial - Portela C S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-07

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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) antibody to anti-HBc (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.
. The subject had to be willing and able to be confined to the clinical unit and had to adhere to the study and lifestyle restrictions.

Exclusion criteria

What they're measuring

Cmax - Maximum observed concentration (for BIA 5-1058)

Timeframe: Up to 2 months and 3 weeks

Tmax - Time corresponding to occurrence of Cmax (for BIA 5-1058)

Timeframe: Up to 2 months and 3 weeks

T½ - Apparent terminal elimination half life (for BIA 5-1058)

Timeframe: Up to 2 months and 3 weeks

Cmax,ss - Maximum observed concentration at steady state (for sildenafi)

Timeframe: Up to 2 months and 3 weeks

Tmax,ss - Time corresponding to occurrence of Cmax,ss at steady state (for sildenafi)

Timeframe: Up to 2 months and 3 weeks

T½,ss - Apparent terminal elimination half-life at steady state (for sildenafi)

Timeframe: Up to 2 months and 3 weeks