Evaluation of the contribution of lupus in the distribution of statins to the liver.

Evaluation of the effect of systemic lupus erythematosus on the activity of the OATP1B1 transporter using atorvastatin PK-PD.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-6p37zr

Enrollment

Unknown

Registered

2020-01-27

Start date

2016-02-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Interventions

The study was divided into three groups: the healthy volunteer group (n = 15), the controlled SLE patient group (SLEDAI 0-4

n = 15) and the uncontrolled SLE patient group (SLEDAI 6- 15

n = 15). After signing the Informed Consent Form, the healthy volunteers and patients with SLE were admitted to the HCFMRP-USP Clinical Research Unit. Considering that pharmacodynamics variation is pe

0.25

0.5, 1, 2, 3, 4 and 6 hours after drug administration. Simultaneously, participants were investigated for baseline levels and circadian rhythm of plasma MVA concentrations. Serial samples of 3 mL of b

0.5

1.5

22 and 24 hours, simulating the same collection times for the analysis of plasma concentrations of ATV. After centrifugation of th

Drug

D26.310

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Healthy Volunteers Group: no active chronic kidney disease; no clinical and laboratory evidence of inflammation; no diagnosis of lupus; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage). Uncontrolled SLE Patients Group: SLEDAI scores between 6 and 12; no active chronic kidney disease; with clinical and laboratory evidence of inflammation; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage). Controlled SLE patients group: SLEDAI scores between 0 and 5; no active chronic kidney disease; with clinical and laboratory evidence of inflammation; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).

Exclusion criteria

Exclusion criteria: History of severe chronic obstructive pulmonary disease; healthy patients or volunteers treated with MDR1, OATP1B1 and CYP3A inducers or inhibitors.

Design outcomes

Primary

Measure	Time frame
Our hypothesis is that the systemic inflammatory picture presented by SLE patients reduces the OATP1B1 transporter activity assessed by reducing the volume of distribution and clearance of atorvastatin.	—

Secondary

Measure	Time frame
There are no expected secondary outcomes.	—

Countries

Brazil

Contacts

Public ContactVera Lanchote

Faculdade de Ciências Farmacêuticas de Ribeirão Preto da Universidade de São Paulo

lanchote@fcfrp.usp.br+55-16-33154195

Outcome results

None listed

Source: REBEC (via WHO ICTRP)