A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+

• Register: RPEC
• Last refreshed on: 29 April 2024
• Main ID: PER-021-17
• Date of registration: 27/11/2017
• Prospective Registration: No
• Primary sponsor: SABELL PERU SAC,
• Public title: A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+
• Scientific title: A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+
• Date of first enrolment: 17/07/2017
• Target sample size: 30
• Recruitment status: Pending
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=021-17
• Study type: Interventional
• Study design: A randomized phase I open label clinical trial to evaluate the safety and tolerability of multiple and ascending doses of A4 + (750 mg, 1500 mg, 2250 mg) in healthy volunteers
• Phase: I

Countries of recruitment

Peru

Contacts

• Name: Braulio Mark Arroyo Valencia
• Affiliation: SABELL PERU SAC

• Name: Braulio Mark Arroyo Valencia
• Affiliation: SABELL PERU SAC

Key inclusion & exclusion criteria

Inclusion criteria:
• Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start.
• Volunteers signing the informed consent form to take part in the clinical trial.
• Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months.
• Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator.

Exclusion criteria: • Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start. • Volunteers signing the informed consent form to take part in the clinical trial. • Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months. • Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator. • Volunteers with any known chronic disease or diagnosed during the evaluation process or who have symptoms of an acute disease. • Pregnant, postpartum or breastfeeding women. • Childbearing women who wish to become pregnant within 3 months after the clinical trial start. • Volunteers taking any type of drug or vitamin supplement. • Subjects who have participated in other study within the last 30 days prior this clinical trial. • Subjects with legal or pending medical lawsuit. • Subjects with any inflammatory disease that may potentially increase C-reactive protein. • Subjects with any mental disorder which disables their comprehension. • Subjects with kidney stones or prone to develop kidney stones. • Subjects who have used depot hormonal contraceptives. • Subjects with history of addictions (e.g. alcohol, tobacco, illegal drugs, medications, compulsive gambling, etc.) which may interfere with the clinical trial or may not allow a correct monitoring.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

-K73

K73

Intervention(s)

Sixty (60) healthy volunteers, divided into three experimental groups composed of 20 subjects, will be assessed and will receive A4+ for 30 days as follows: Study Group 1 (750 mg: one tablet of 250 mg every 8 hours), Study Group 2 (1500 mg: two tablets of 250 mg every 8 hours), and Study Group 3 (2250 mg: three tablets of 250 mg every 8 hours)

Source(s) of Monetary Support

SABELL PERU SAC

Ethics review

Status: Approved
Approval date: 11/01/2017
Contact:

[e-mail]

Hospital Nacional Edgardo Rebagliati Martins

2654901-3080 2640516

[e-mail]