CLINICAL TRIALS AND PHARMACOKINETICS OF AC-1370

Abstract

AC-1370 was administered to 16 cases (respiratory tract infections 10 cases; urinary tract infections 3 cases; biliary tract infections 2 cases). They received 0.5-2.0g of AC-1370 by intravenous injection over a period of 3-5 minutes or 30-60 minutes once or twice daily. One case was excluded from the evaluation of clinical effect (Case 16 was prophylactic chemotherapy). Clinical effects of 15 cases were excellent in 3 cases (2 cases of respiratory tract infections, one case of urinary tract infection), good in 9 cases (5 cases of respiratory tract infections, 2 cases of urinary tract infections, 2 cases of biliary tract infections), fair in one case of respiratory tract infection, and poor in 2 cases of respiratory tract infections. Among 16 cases treated with AC-1370, serious adverse reactions were not observed.
Serum and urine levels of AC-1370 were studied in 4 cases during the therapy with AC-1370. Elevation of serum levels and prolongation of serum half-life of AC-1370 correlated with the degree of renal dysfunction. Urinary excretion of AC-1370 decreased in parallel with the degree of renal dysfunction. Dosage modification of AC-1370 is necessary in patients with renal dysfunction.