Conditions: Breast Cancer
Keywords: Breast cancer Healthy volunteers Pharmacokinetics AZD9496 Safety Tolerability
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: yes

Brief summary:
This is a phase 1 open label single centre study of AZD9496 administered orally in healthy volunteers. The study design involves single administration of different forms, formulations and doses of AZD9496. The study is designed to investigate these different AZD9496 variants. The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the different forms, formulations and doses of AZD9496

This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers. Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and doses.

Detailed description:
A phase 1, open-label, single centre study to assess the pharmacokinetics, Safety and tolerability of different forms, formulations and doses of AZD9496 in healthy volunteers. This is a fixed sequence study with 5-sequential treatment periods. Each subject will receive 5 single doses of AZD9496 in different forms, formulations and doses.

* Treatment period one will assess AZD9496 Variant A: 100mg.
* Treatment period two will assess AZD9496 Reference form: 100mg.
* Treatment period 3 will assess one of AZD9496 Variants, B, C or D: 100mg.
* Treatment period 4 will assess one of AZD9496 Variants, B, C or D: 100mg.
* Treatment period 5 will assess one of AZD9496 Variants A, B, C or D: \*300mg. \*Based on a review of pharmacokinetic and safety results from Treatment Periods 1, 3 and 4, a lower dose of 200 mg may be administered in Treatment Period 5.

Arms:
arm 1: This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers. Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and doses.

1. Treatment period 1 will assess AZD9496 Variant A: 100mg.
2. Treatment period 2 will assess AZD9496 Reference: 100mg.
3. Treatment period 3 will assess one of AZD9496 Variants, B, C or D: 100mg.
4. Treatment period 4 will assess one of AZD9496 Variants, B, C or D: 100mg.
5. Treatment period 5 will assess one of AZD9496 Variants A, B, C or D: \*300mg. \*Based on a review of PK and safety results from Treatment Periods 1, 3 and 4, a lower dose of 200 mg may be administered in Treatment Period 5

Interventions: intervention 1: AZD9496 (Reference) intervention 2: AZD9496 Variant A intervention 3: AZD9496 Variant B intervention 4: AZD9496 Variant C intervention 5: AZD9496 Variant D
Intervention descriptions: intervention 1: AZD9496 (Reference) intervention 2: AZD9496 Variant A. intervention 3: AZD9496 Variant B intervention 4: AZD9496 Variant C intervention 5: AZD9496 Variant D

Protocol document: