Capivasertib for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Diabetes, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how capivasertib, an experimental treatment, affects the body's processing of rosuvastatin, a drug commonly used to lower cholesterol. Participants will first take rosuvastatin alone, then both drugs together, to compare the effects. Individuals in good health, with no major medical issues, who do not smoke and have normal blood test results, are suitable for this study. The trial focuses on understanding drug interactions to enhance treatment plans. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants and involves assessing drug interactions, it's possible that you may need to pause some medications. Please consult with the study team for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that capivasertib has been tested on many patients, with its safety well-documented. In one study, about 10% of patients stopped taking capivasertib due to side effects. However, approximately 39% of patients paused their treatment, usually because of milder side effects.

Capivasertib has been used with other drugs, such as fulvestrant, and its safety was consistent across different groups, including a group from China. No unexpected safety issues emerged when capivasertib was combined with another drug.

Although capivasertib has been extensively studied, this trial is in its early stages (Phase 1), focusing primarily on safety. The researchers are still gathering safety information. However, existing data suggests the treatment is generally well-tolerated in other settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Capivasertib is unique because it targets a specific pathway called the AKT pathway, which plays a crucial role in cell growth and survival. Unlike other treatments that might not target this pathway, Capivasertib's mechanism of action offers a new angle for tackling conditions related to this pathway. Researchers are excited about this treatment because it could potentially improve outcomes by directly interfering with the growth signals of abnormal cells, offering new hope where traditional therapies may have limitations.

What evidence suggests that this trial's treatments could be effective?

Research has shown that Capivasertib affects how the body processes other drugs, such as rosuvastatin. In this trial, participants will first receive a single dose of rosuvastatin, followed by a combination of Capivasertib and rosuvastatin after a washout period. Studies with healthy individuals found that Capivasertib alters the absorption, distribution, and elimination of rosuvastatin. Although this study focuses on healthy participants, Capivasertib has demonstrated significant benefits in other conditions, such as prolonging the time cancer patients live without disease progression when combined with other treatments. This suggests that Capivasertib can work well with other drugs and might offer benefits when used with rosuvastatin. However, as this is an early study, the primary goal is to understand how these two drugs interact in the body. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults with good veins for blood draws, a BMI of 18-32 kg/m², and weight between 50-150 kg. Women must not be pregnant or breastfeeding and may need to be postmenopausal or surgically sterile. Men should be vasectomized. All participants must agree to use contraception.

Inclusion Criteria

My BMI is between 18 and 32, and I weigh between 50kg and 150kg.

I am willing to follow the study's birth control requirements.

Key

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment Period 1

Participants receive a single oral dose of rosuvastatin

3 days

1 visit (in-person)

Washout

Minimum washout period between doses of rosuvastatin

1 week

Treatment Period 2

Participants receive two single oral doses of capivasertib administered 12 hours apart, with the first dose concomitantly with rosuvastatin

3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Capivasertib
• Rosuvastatin

Trial Overview The study is testing how the drug Capivasertib affects the body's handling of Rosuvastatin, a cholesterol medication, in healthy individuals. It measures changes in drug levels when both drugs are taken together.

How Is the Trial Designed?

Group I: Rosuvastatin/Capivasertib+Rosuvastatin Experimental Treatment 2 Interventions

Participants will receive a single dose of rosuvastatin in Period 1. After a minimum washout period of 7 days from the first dose of rosuvastatin, participants will receive the first dose of capivasertib, administered concomitantly with a single dose of rosuvastatin in Period 2, followed by a second dose of capivasertib after 12 hours.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D3615C00006

A study to investigate the effect of capivasertib ... The purpose of the study is to assess the effect of capivasertib on the pharmacokinetics (PK) of oral rosuvastatin in healthy participants.

2. patlynk.com patlynk.com/trial/NCT07088913

Capivasertib Impact on Rosuvastatin Pharmacokinetics in ... This clinical trial aims to study how the drug capivasertib affects the body's processing of another drug, rosuvastatin, in healthy individuals.

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-6-2025-41a8d

Capivasertib for Healthy Subjects This Phase 1 medical study run by AstraZeneca is evaluating whether Capivasertib and Rosuvastatin will have tolerable side effects & efficacy for patients ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612198/

Clinical Review - Capivasertib (Truqap) - NCBI Bookshelf - NIH The trial showed high and moderate certainty of evidence that treatment with capivasertib plus fulvestrant results in a clinically meaningful increase in PFS ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/546193-a-study-to-investigate-the-effect-of-capivasertib-on-the-pharmacokinetics-of-oral-rosuvastatin-in-healthy-participants

Study on How Capivasertib Affects Rosuvastatin in Healthy ... This clinical research study is designed to understand how a new drug called capivasertib might affect how the body processes another ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953117/

An exposure–safety analysis to support the dosage of ... This study aimed to evaluate capivasertib exposure–response relationships for clinical safety events to support dosage selection.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/218197Orig1s000MultidisciplineR.pdf

NDA/BLA Multi-disciplinary Review and Evaluation the renal clearance of capivasertib in healthy subjects is less than 30% and that 7.4% of the ... (PMC) to provide additional data on safety and efficacy of ...

8. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.70286

Population Pharmacokinetics and Exposure–Response ... The safety profile of capivasertib + fulvestrant in the Chinese cohort was broadly consistent with the global population, with no new safety ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214131

Capivasertib in Hormone Receptor–Positive Advanced ... Safety. The safety population included 355 patients who received capivasertib–fulvestrant and 350 who received placebo–fulvestrant. The most ...

10. truqaphcp.com truqaphcp.com/safety

Safety Profile | TRUQAP® (capivasertib) Tablets | For HCPs Permanent TRUQAP discontinuation due to an adverse reaction occurred in 10% of patients. Dose interruptions of TRUQAP occurred in 39% of patients. DRUG ...