METHODS OF TREATMENT WITH DEUTERATED CFTR POTENTIATORS
Disclosed is a method of treating in a subject of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator. The method comprises administering to the subject Compound (I): or pharmaceutically acceptable salts thereof, together with food. Also disclosed are products comprising Compound (I) and the use of such products.
1 . A method of treating a condition that is mediated by CFTR in a subject comprising orally administering to the subject an effective amount of Compound (I):
or a pharmaceutically acceptable salt thereof;
wherein the Compound (I) is administered to the subject with food containing less than 60 g of fat.
2 . The method of claim 1 , wherein the condition is cystic fibrosis.
3 . The method of claim 1 , wherein 50-200 mg of Compound (I), or a pharmaceutically acceptable salt thereof, is administered to the subject.
4 . The method of claim 1 , wherein Compound (I), or a pharmaceutically acceptable salt thereof, is administered once per day.
5 . The method of claim 1 , wherein the compound is administered in a pharmaceutical formulation which is a tablet.
6 . The method of claim 1 , wherein the compound is administered in a pharmaceutical formulation which is a granule.
7 . The method of claim 1 , wherein any atom not designated as deuterium in Compound (I) is present at its natural isotopic abundance.
8 . The method of claim 7 , wherein the plasma concentration of Compound (I) in the subject at 16 hours after administration is about 1.5-2-fold greater than the plasma concentration of Compound (I) at 16 hours when the Compound (I) is administered without food.
9 . The method of claim 8 , wherein the subject is a human adult or a pediatric patient 6 years and older.
10 . The method of claim 9 , wherein the food contains less than about 30 g of fat.
11 . The method of claim 10 , wherein the food contains less than about 20 g of fat.
12 . The method of claim 11 , wherein the food contains less than about 10 g of fat.
13 . The method of claim 9 , wherein the food contains between 0 and about 50 g of fat.
14 . The method of claim 9 , wherein the food contains between about 5 and about 20 g of fat.
15 . The method of claim 14 , wherein the food comprises cheese.
16 . The method of claim 15 , wherein the condition is cystic fibrosis and the subject has one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, and R117H.
17 . A product comprising: a) an oral dosage form comprising an effective amount of Compound (I):
or a pharmaceutically acceptable salt thereof; and b) prescribing information for administering the oral dosage form, wherein the prescribing information includes: i) dosage and administration information for adults and pediatric patients 6 years and older instructing the administration of 50-200 mg of Compound (I) taken orally once per day with food containing less than 60 g of fat.