DIQTA 1.0: Drug-Induced QT Prolongation Atlas

AVANAFIL

Classification:Ambiguous

Severity Score:1.0

CLINICAL PHARMACOLOGY
Pharmacodynamics
Effects on Cardiac Electrophysiology
The effect of single 100 or 800 mg doses of STENDRA on the QT interval were evaluated in a randomized, double-blind, placebo, and active (moxifloxacin) –controlled crossover study in 52 healthy male subjects aged 18 to 45 years. There were no significant effects of the 100 mg dose. The mean QTc (Fridericia QT correction) for avanafil 800 mg, relative to placebo was 9.4 milliseconds (two-sided 90% CI=7.2, 11.6). An 800 mg dose of STENDRA (4 times the highest recommended dose) was chosen because this dose yields exposures greater than those observed upon co-administration of avanafil with strong CYP3A4 inhibitors. A double-blind, randomized, placebo- and active-controlled (moxifloxacin), thorough QT/QTc trial of STENDRA (100 and 800 mg) in healthy male subjects demonstrated that STENDRA did not cause any significant changes in QTc interval or ventricular repolarization.

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

38381587

Odds Ratio = N/A

ATC Code(s):

Active Ingredient:AVANAFIL

Active Ingredient UNII:DR5S136IVO

Drugbank ID:DB06237

PubChem Compound:9869929

CTD ID:C553414

PharmGKB:

CAS Number:330784-47-9

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
COC1=C(Cl)C=C(CNC2=C(C=NC(=N2)N2CCC[C@H]2CO)C(=O)NCC2=NC=CC=N2)C=C1

[Smith W B,McCaslin I R,Gokce A,Mandava S H,Trost L,Hellstrom W J]
Int J Clin Pract,2013 Aug;67(8):768-80. PMID: 23869678