Effect of Food on BIA 5-1058

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Effect of Food on BIA 5-1058 Bioavailability in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991155
• Other study ID #: BIA-51058-102
• Secondary ID: 2015-001951-65
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2015
• Est. completion date: September 22, 2015

Study information

• Verified date: July 2021
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Single-centre, open-label, randomised, single-dose, three-way crossover, three-part study in 54 healthy subjects.

Duration of treatment:

The study comprised a screening evaluation between 2 and 28 days before the first IMP (Investigational Medicinal Product) administration and 3 treatment periods of approximately 4 days, separated by wash-out periods of at least 7 days. A follow-up visit was performed approximately 7 days after discharge from the last period or early discontinuation. For each subject, the full duration of the participation in the study was approximately 9 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 22, 2015
• Est. primary completion date: September 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Able and willing to give written informed consent and to comply with the study restrictions;

2. Male or female subjects aged 18 to 45 years, inclusive;

3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;

4. Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);

5. 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;

6. Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;

7. Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;

8. Non-smokers or ex-smokers for at least 3 months.

If female:

9. No childbearing potential by reason of surgery or at least 1 year post menopause (i.e., 12 months post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing;

10. If of childbearing potential, she was using an effective non-hormonal method of contraception [intrauterine device or intrauterine system; condom or occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject] for all the duration of the study;

11. Negative serum pregnancy test at screening and negative urine pregnancy test on admission of each treatment period (women of childbearing potential only).

If male:

12. Using an effective method of contraception with a pregnant partner or partner of childbearing potential (condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomy) throughout the study;

13. Refraining from donating sperm throughout the study.

Exclusion Criteria:

1. 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;

2. Clinically relevant surgical history;

3. History of relevant atopy or drug hypersensitivity;

4. History of alcoholism or drug abuse;

5. 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];

6. Significant infection or known inflammatory process at screening or admission to each treatment period;

7. Display of acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;

8. 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;

9. Previous administration of BIA 5-1058;

10. Use of any investigational drug or participation in any clinical trial within 90 days prior to screening;

11. Participation in more than 2 clinical trials within the 12 months prior to screening;

12. Donation or reception of any blood or blood products within the 3 months prior to screening;

13. Vegetarians, vegans or had any other medical dietary restrictions;

14. Not able to communicate reliably with the Investigator;

15. Unlikely to co-operate with the requirements of the study.

If female:

16. Pregnant or breastfeeding;

17. Not using an accepted effective contraceptive method or was using oral contraceptives.

If male:

18. Not using an accepted effective method of contraception;

19. Refusing to refrain from donating sperm throughout the study.

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• BIA 5-1058
BIA 5-1058 (tablets 100 mg) was administered orally with 240 mL (Part 1) or 270 mL (Part 2 and Part 3) of water, in one period in the morning under fasting conditions (after at least a 10-hour overnight fast), in one period in the morning after a moderate meal, and in the other period at lunch after a moderate meal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)	In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose	Up to 9 weeks
Primary	Time of occurrence of Cmax (tmax)	In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose	Up to 9 weeks
Primary	Area under the plasma concentration-time curve (AUC)	In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose	Up to 9 weeks
Primary	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)	In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose	Up to 9 weeks