CompletedPhase 1

Effect of Food on BIA 5-1058

57 participantsStarted 2015-07-20

Plain-language summary

The aim of this study is to investigate the effect of food on the pharmacokinetic (PK) profile of BIA 5-1058 after a single dose in healthy subjects.

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

. Able and willing to give written informed consent and to comply with the study restrictions;
. Male or female subjects aged 18 to 45 years, inclusive;
. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
. Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
. Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;
. Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
. Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
. Non-smokers or ex-smokers for at least 3 months.

Exclusion criteria

. Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;

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

Maximum observed plasma concentration (Cmax)

Timeframe: Up to 9 weeks

Time of occurrence of Cmax (tmax)

Timeframe: Up to 9 weeks

Area under the plasma concentration-time curve (AUC)

Timeframe: Up to 9 weeks

Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which the drug concentration was at or above the lower limit of quantification (AUC0-last)

Timeframe: Up to 9 weeks

Trial details

NCT IDNCT04991155

SponsorBial - Portela C S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-09-22

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

. Able and willing to give written informed consent and to comply with the study restrictions;
. Male or female subjects aged 18 to 45 years, inclusive;
. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
. Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
. Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;
. Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
. Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
. Non-smokers or ex-smokers for at least 3 months.

Exclusion criteria

. Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;

What they're measuring

Maximum observed plasma concentration (Cmax)

Timeframe: Up to 9 weeks

Time of occurrence of Cmax (tmax)

Timeframe: Up to 9 weeks

Area under the plasma concentration-time curve (AUC)

Timeframe: Up to 9 weeks

Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which the drug concentration was at or above the lower limit of quantification (AUC0-last)

Timeframe: Up to 9 weeks