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 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

✓. 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

✕. 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.

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 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

✓. 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

✕. 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.

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