An Open-label, Randomized, Cross Over Single Oral Dose Study Comparing the Pharmacokinetics of Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Male Subjects

NCT02560363 Phase 1 WITHDRAWN

This is an open-label, randomized, cross over single oral dose study to compare the pharmacokinetics of different formulations of AZD9977 in Part A and the influence of food in Part B in healthy male subjects

Details

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	WITHDRAWN
Start date	2015-11
Completion	2016-01

Conditions

• Pharmacokinetics
• Healthy Male Subjects
• Safety
• Food Effect

Interventions

• AZD9977 immediate release (IR) oral suspension
• AZD9977 extended release (ER) capsules [fast]
• AZD9977 extended release (ER) capsules [intermediate]
• AZD9977 extended release (ER) capsules [slow]

Primary outcomes

• Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC) — Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
  Relative bioavailability (Frel \[AUC\]) by assessement of the ratio of AUC (Area under plasma concentration-time curve from time zero extrapolated to infinity) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
• Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC0-t) — Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
  Relative bioavailability (Frel \[AUC0-t\]) by assessement of the ratio of AUC (Area under the plasma concentration-curve from time zero to time of last quantifiable concentration) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
• Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (AUC0-24) — Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
  Relative bioavailability (Frel \[AUC0-24\]) by assessement of the ratio of AUC (Area under the plasma concentration-time curve from time zero to 24 hours post-dose) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
• Rate and extent of absorption of the extended-release formulations in comparison with an immediate-release formulation of AZD9977 by assessment of Frel (Cmax) — Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
  Relative bioavailability (Frel \[Cmax\]) by assessement of the ratio of AUC (Observed maximum plasma concentration) between the extended-release formulations in comparison with an immediate-release formulation of AZD9977
• Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel (AUC) — Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
  Relative bioavailability (Frel \[AUC\]) by assessement of the ratio of AUC (Area under plasma concentration-time curve from time zero extrapolated to infinity) after dosing of an extended-release formulation under fed and fasting conditions
• Rate and extent of absorption of an extended-release formulation of AZD9977 under fasting condtions in comparision with fed condtions by assessment of Frel(AUC0-t) — Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36 and 48 hours post-dose on each dosing day
  Relative bioavailability (Frel \[AUC0-t\]) by assessement of the ratio of AUC (Area under the plasma concentration-curve from time zero to time of last quantifiable concentration) after dosing of an extended-release formulation under fed and fasting conditions

Countries

United Kingdom