Drug-drug Interaction StudyPhase 1NCT06808646

A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin

A Phase 1 study testing pitavastatin and pitavastatin single dose combined with ceftobiprole in people with Drug-drug Interaction Study, run by Basilea Pharmaceutica at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Drug-drug Interaction Study
What is being tested?: pitavastatin and pitavastatin single dose combined with ceftobiprole
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteNetherlands
Study dates: 17 Jan 2025to 25 Feb 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Main Inclusion Criteria:

Body mass index: 18.0 to 30.0 kg/m2, inclusive
Good physical and mental health
Normal renal function (creatinine clearance ≥ 90 mL/min as determined by the Cockcroft-Gault equation)
Female participants of childbearing potential were required not be pregnant or lactating and had to agree to use adequate contraception
Male subjects, if not surgically sterilized, were required to agree to use adequate contraception
All prescribed medication had to be stopped at least 30 days prior to admission to the clinical research center (an exception was made for hormonal contraceptives)
All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) had to be stopped at least 14 days prior to admission to the clinical research center
Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to Screening and admission to the clinical research center
Ability and willingness to abstain from methylxanthine-containing beverages or food from 48 hours (2 days) prior to admission to the clinical research center

Main Exclusion Criteria:

History of relevant drug and/or food allergies, particularly to antibiotics.
Subject received a known potent inhibitor of OATP1B activity within 30 days prior to admission
Subject received a potential inducer of OATP1B activity within 30 days prior to admission
Subject had a history of seizures
Subject had a history of frequent diarrhea
Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily; the use of tobacco products in the 48 hours (2 days) prior to admission
History of alcohol abuse or drug addiction within 12 months prior to Screening.
Average intake of more than 24 units of alcohol per week
Positive drug and/or alcohol screen
Donation or loss of more than 450 mL of blood within 60 days prior to the first pitavastatin administration on Day 1 of the current study. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first pitavastatin administration on Day 1 of the current study.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

ICON Early Clinical & Bioanalytical Solutions
Groningen, 9728

Other trials in Netherlands

About this study

Official title: A Phase 1, Single-center, Open-label, Non-randomized, Fixed-sequence, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Intravenous Ceftobiprole on the Pharmacokinetics of Oral Pitavastatin (OATP1B Substrate) and on Plasma Levels of Coproporphyrin I (OATP1B Biomarker) in Healthy Subjects

The goal of this clinical study was to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of increased levels of cholesterol in blood) from the body. This interaction was investigated by pharmacokinetic (PK) assessments. The clinical study also investigated the safety of ceftobiprole and how well ceftobiprole was tolerated by healthy subjects when it was administered in combination with pitavastatin.

Read the detailed description

This study assessed whether there was an inhibitory effect of ceftobiprole on hepatic organic anion-transporting polypeptide 1B (OATP1B) activity. Pitavastatin was used as an OATP1B substrate in this study. The pharmacokinetics of oral pitavastatin were assessed when administered alone and when administered together with IV ceftobiprole in a study design including 2 treatment periods. In addition, the pharmacodynamic effect of repeated doses of IV ceftobiprole on the diurnal plasma levels of coproporphyrin I (CP-I) was assessed in this study as CP-I is an endogenous biomarker for hepatic OATPB1 activity.

The study duration was up to 38 days.

Conditions: Drug-drug Interaction Study
Being tested: pitavastatin, pitavastatin single dose combined with ceftobiprole
Keywords: Ceftobiprole, Pitavastatin, OATP1B, Coproporphyrin, DDI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pitavastatinDrug
Single oral administration
pitavastatin single dose combined with ceftobiproleDrug
Single oral pitavastatin co-administered with IV ceftobiprole

Study groups in NCT06808646
Study group	Role	What they receive
Period 1; pitavastatin 2 mg	Experimental	On Day 1, a single oral dose of pitavastatin was administered Receives: Drug: pitavastatin
Period 2; pitavastatin 2 mg combined with ceftobiprole 500 mg	Experimental	From Day 4 to Day 7, ceftobiprole (as the prodrug ceftobiprole medocaril sodium) will be administered intravenously (IV) every 8 hours (q8h) for four days. On Day 6, a single oral dose of pitavastatin will be co-administered with ceftobiprole From Day 4 to Day 7, 500 mg ceftobiprole (as the prodrug ceftobiprole medocaril sodium) was administered as a 2-hour IV dose every 8 hours (q8h) under fasted conditions in the morning, and irrespective of timing of food intake further on the day. On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole under fasted conditions. Receives: Drug: pitavastatin single dose combined with ceftobiprole

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Pitavastatin
To assess the pharmacokinetic parameter Cmax in plasma after a single oral dose of pitavastatin administered without and with intravenous (IV) ceftobiprole
Measured: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
Area Under the Plasma Concentration-time Curve up to Time (AUC0-t) After Pitavastatin Administration
To assess the pharmacokinetic parameter AUC0-t after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Measured: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) After Pitavastatin Administration
To assess the pharmacokinetic parameter AUC0-inf after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Measured: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose

Secondary outcomes (8)

Cmax of Coproporphyrin I (CP-I)
The pharmacokinetic parameter Cmax for CP-I in plasma was assessed with and without administration of IV ceftobiprole
Measured: Sampling on Day 5; pre-dose, 2, 4, 6, 8 h, 16, and 25.5 (Day 6) hours post-dose and corresponding samples on Day -1
Area Under the Plasma Level-time Curve up to Time 25.5 Hours (AUEC0-25.5h) of CP-I in Plasma
The pharmacokinetic parameter AUEC0-25.5h for CP-I was assessed with and without administration of IV ceftobiprole
Measured: Sampling on Day 5; pre-dose, 2, 4, 6, 8 h, 16, and 25.5 (Day 6) hours post-dose and corresponding samples on Day -1
Cmax of Ceftobiprole in Plasma
To assess the pharmacokinetic parameter Cmax of IV ceftobiprole without and with oral administration of pitavastatin
Measured: Sampling on Day 5: pre-dose ,1, 2, 4, 6, 8 h post-dose, on Day 6; pre-dose,1, 2, 4, 6, 8 h post-dose
Area Under the Plasma Concentration-time Curve up to 8 Hours (AUC0-8h) After IV Ceftobiprole
To assess the pharmacokinetic parameter AUC0-8h after IV ceftobiprole without and with oral administration of pitavastatin
Measured: Sampling on Day 5: pre-dose ,1, 2, 4, 6, 8 h post-dose, on Day 6; pre-dose,1, 2, 4, 6, 8 h post-dose
Cmax of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
To assess the pharmacokinetic parameter Cmax of pitavastatin lactone after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Measured: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
AUC0-t of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
To assess the pharmacokinetic parameter AUC0-t of pitavastatin lactone after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Measured: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
AUC0-inf of of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
To assess the pharmacokinetic parameter AUC0-inf of pitavastatin lactone after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Measured: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) After Administration of Ceftobiprole Without and With a Single Oral Dose of Pitavastatin
A treatment-emergent AE (TEAE) was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
Measured: Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 202525 Feb 2025

First posted5 Feb 2025
Study start17 Jan 2025
Primary completion25 Feb 2025
Study completion25 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Drug-drug Interaction StudyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06808646
Sponsor's protocol ID: BPR-CP-101
Other IDs: HHSO100201600002C, 2024-518592-60-00
Status last verified: Mar 2026
First submitted: 9 Jan 2025
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-center, Open-label, Non-randomized, Fixed-sequence, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Intravenous Ceftobiprole on the Pharmacokinetics of Oral Pitavastatin (OATP1B Substrate) and on Plasma Levels of Coproporphyrin I (OATP1B Biomarker) in Healthy Subjects
ClinicalTrials.gov ID: NCT06808646
Acronym / sponsor ID: BPR-CP-101
Conditions: Drug-drug Interaction Study
Keywords: Ceftobiprole, Pitavastatin, OATP1B, Coproporphyrin, DDI
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Basilea PharmaceuticaIndustry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 17 Jan 2025 (actual)
Primary completion: 25 Feb 2025 (actual)
Study completion: 25 Feb 2025 (actual)
First posted: 5 Feb 2025 (actual)
Results: Posted 21 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study duration was up to 38 days.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Period 1; pitavastatin 2 mg	Experimental	Drug: pitavastatinOn Day 1, a single oral dose of pitavastatin was administered
Period 2; pitavastatin 2 mg combined with ceftobiprole 500 mg	Experimental	Drug: pitavastatin single dose combined with ceftobiproleFrom Day 4 to Day 7, ceftobiprole (as the prodrug ceftobiprole medocaril sodium) will be administered intravenously (IV) every 8 hours (q8h) for four days. On Day 6, a single oral dose of pitavastatin will be co-administered with ceftobiprole From Day 4 to Day 7, 500 mg ceftobiprole (as the prodrug ceftobiprole medocaril sodium) was administered as a 2-hour IV dose every 8 hours (q8h) under fasted conditions in the morning, and irrespective of timing of food intake further on the day. On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole under fasted conditions.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pitavastatinSingle oral administration	Drug	Period 1; pitavastatin 2 mg
pitavastatin single dose combined with ceftobiproleSingle oral pitavastatin co-administered with IV ceftobiprole	Drug	Period 2; pitavastatin 2 mg combined with ceftobiprole 500 mg

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Pitavastatin
Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
To assess the pharmacokinetic parameter Cmax in plasma after a single oral dose of pitavastatin administered without and with intravenous (IV) ceftobiprole
Area Under the Plasma Concentration-time Curve up to Time (AUC0-t) After Pitavastatin Administration
Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
To assess the pharmacokinetic parameter AUC0-t after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) After Pitavastatin Administration
Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
To assess the pharmacokinetic parameter AUC0-inf after a single oral dose of pitavastatin administered without and with IV ceftobiprole

8 secondary outcomes

Cmax of Coproporphyrin I (CP-I)
Time frame: Sampling on Day 5; pre-dose, 2, 4, 6, 8 h, 16, and 25.5 (Day 6) hours post-dose and corresponding samples on Day -1
Area Under the Plasma Level-time Curve up to Time 25.5 Hours (AUEC0-25.5h) of CP-I in Plasma
Time frame: Sampling on Day 5; pre-dose, 2, 4, 6, 8 h, 16, and 25.5 (Day 6) hours post-dose and corresponding samples on Day -1
Cmax of Ceftobiprole in Plasma
Time frame: Sampling on Day 5: pre-dose ,1, 2, 4, 6, 8 h post-dose, on Day 6; pre-dose,1, 2, 4, 6, 8 h post-dose
Area Under the Plasma Concentration-time Curve up to 8 Hours (AUC0-8h) After IV Ceftobiprole
Time frame: Sampling on Day 5: pre-dose ,1, 2, 4, 6, 8 h post-dose, on Day 6; pre-dose,1, 2, 4, 6, 8 h post-dose
Cmax of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
AUC0-t of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
AUC0-inf of of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) After Administration of Ceftobiprole Without and With a Single Oral Dose of Pitavastatin
Time frame: Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6

Results and safety

Results posted to the registry on 21 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Entire Population of Subjects	12	12

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Pitavastatin

Time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose. Geometric mean (Full Range). Unit: ng/mL

Measure	Period 1; Pitavastatin 2 mg n = 12	Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg n = 12
Value	42.79 (12.80 to 98.70)	33.54 (8.69 to 98.70)

Population analysed: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter

Primary outcome: Area Under the Plasma Concentration-time Curve up to Time (AUC0-t) After Pitavastatin Administration

Measure	Period 1; Pitavastatin 2 mg n = 12	Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg n = 12
Value	100.29 (32.7 to 235.0)	86.63 (39.1 to 226.5)

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) After Pitavastatin Administration

Measure	Period 1; Pitavastatin 2 mg n = 12	Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg n = 12
Value	105.42 (35.3 to 241.4)	91.59 (42.0 to 232.5)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pitavastatin Period 1	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Ceftobiprole Period 2	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Pitavastatin + Ceftobiprole Period 2	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Kaindl, MD study director

Basilea Pharmaceutica International Ltd, Allschwil

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pitavastatin and pitavastatin single dose combined with ceftobiprole in people with Drug-drug Interaction Study, run by Basilea Pharmaceutica at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Pitavastatin (time frame: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06808646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.