Food-Effect Bioavailability Study of AQ-13, a Candidate Antimalarial

This is a 2-stage, randomized crossover study of a 2100 mg AQ-13 dose in healthy volunteers. Fourteen healthy volunteers will be randomized to receive the drug either on an empty stomach or after a standard fatty meal under continuous monitoring in the hospital. After a washout period of 8 weeks, the volunteers will be admitted to the hospital again to receive the same dose of the drug after a fatty meal or on an empty stomach in reverse - so each volunteer will receive AQ-13 with and without a fatty meal.

Study Population:

Healthy young men and women, 21-45 years of age who are taking no chronic medications with the exception of birth control pills will be invited to participate in this food-effect bioavailability study at the Tulane-LSU General Clinical Research Center in New Orleans. Exclusion criteria include pregnancy, breast feeding, abnormal liver or kidney function tests, anemia (Hb < 12 gm per dL), chronic medications other than birth control pills, and an abnormal baseline ECG or Holter recording.

Randomization:

Allocation codes will be generated by the biostatistician in blocks, using computer software, and will be sealed in numbered, opaque envelopes. Block sizes will be determined at random and will not be known to the study personnel. The envelopes containing the randomization codes will be hand-delivered to the study pharmacist and kept in the Research Pharmacy, which is outside the GCRC.