CompletedPhase 1

Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants

Germany48 participantsStarted 2021-07-26

Plain-language summary

This is a two-part, open-label, randomized, crossover study in healthy subjects (vasectomized males and women of non-childbearing potential), performed at 2 study centers

Who can participate

Age range18 Years – 58 Years

SexALL

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Inclusion criteria

✓. Postmenopausal defined as aged \> 40 years and amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
✓. Documentation of irreversible/permanent surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation, at least 6 months prior to screening.

Exclusion criteria

✕. Diagnosis of diabetes mellitus type I or II (irrespective of management).
✕. Blood glucose value ≥ 5.9 mmol/L after fasting for at least 8 hours, at screening or on admission to study center.
✕. Glycosylated hemoglobin \> upper limit of normal (up to 6.2% \[44 mmol/mol\]).

What they're measuring

Cmax of Capivasertib

Timeframe: Part 1 and Part 2: From Day 1 to Day 3

AUCinf of Capivasertib

Timeframe: Part 1 and Part 2: From Day 1 to Day 3

AUClast of Capivasertib

Timeframe: Part 1 and Part 2: From Day 1 to Day 3

Trial details

NCT IDNCT04944771

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-04

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