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 range18 Years – 45 Years

SexALL

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;
✕. Clinically relevant surgical history;
✕. History of relevant atopy or drug hypersensitivity;
✕. History of alcoholism or drug abuse;
✕. Consumption of more than 14 units of alcohol a week \[1 glass (25 cL) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cL) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cL) of wine with 10° of alcohol = 12 g, or 1 glass (4cL) of aperitif with 42° of alcohol = 17 g\];
✕. Significant infection or known inflammatory process at screening or admission to each treatment period;
✕. Display of acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
✕. Use of medicines within 2 weeks of admission to the first period that may could affect the safety or other study assessments, in the Investigator's opinion;

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 range18 Years – 45 Years

SexALL

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;
✕. Clinically relevant surgical history;
✕. History of relevant atopy or drug hypersensitivity;
✕. History of alcoholism or drug abuse;
✕. Consumption of more than 14 units of alcohol a week \[1 glass (25 cL) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cL) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cL) of wine with 10° of alcohol = 12 g, or 1 glass (4cL) of aperitif with 42° of alcohol = 17 g\];
✕. Significant infection or known inflammatory process at screening or admission to each treatment period;
✕. Display of acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
✕. Use of medicines within 2 weeks of admission to the first period that may could affect the safety or other study assessments, in the Investigator's opinion;

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