Healthy SubjectsPhase 1NCT05644600
A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants.
A Phase 1 study testing Nintedanib and AZD5055 in people with Healthy Subjects, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The study is intended to quantify the effect of co-administration and staggered dosing of AZD5055 and nintedanib on exposures of nintedanib in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Nintedanib and AZD5055
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 May 2023to 17 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy nonsmoking male and female (of non-childbearing potential) participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test, must not be lactating and must be of non childbearing potential.
- Male participants and their woman partners of childbearing potential must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of chronic gastrointestinal, hepatic, or renal disease, any acute disease in these organs, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP (Investigational Medicinal Product).
- Untreated TB (Tuberculosis) or a positive result for the IGRA (Interferon Gamma Release Assay) (ie, QuantiFERON TB Gold).
- Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) .
- History of severe COVID-19 (corona virus) infection requiring hospitalisation within the last 12 months prior to Screening, or clinical history compatible with Long COVID-19 (symptoms beyond 12 weeks of acute infection).
Show all 15Show fewer
- Has received live or live attenuated vaccine in the 30 days prior to dosing, the first dose of COVID-19 vaccine within 30 days prior to randomisation, or a COVID-19 vaccine second or booster vaccination within 10 days of Screening.
- History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
- History of a traumatic fracture within 6 months of Screening.
- Any laboratory values with the following deviations:
- Alanine aminotransferase > ULN (2) Aspartate aminotransferase > ULN (3) Total bilirubin > ULN (4) White blood cell count < 3.5 × 109/L (5) Platelet < LLN (6) eGFR < 90 ml/min/1.73 m2 (Cockroft-Gault or CKD-EPI formula) 11. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (Electrocardiogram) and any clinically important abnormalities in the 12-lead ECG .
- 12. Any positive result on Screening for active hepatitis A, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibody, or any known chronic/active liver diseases.
- 13. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5055 or nintedanib.
- 14. Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
- 15. Subjects who have previously received AZD5055.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.
The study is intended to quantify the effect of co-administration and staggered dosing of AZD5055 and nintedanib on exposures of nintedanib in healthy participants.
Read the detailed description
This study will be an open-label, randomised, crossover study in healthy participants (males and females of non-childbearing potential).
The study will comprise two parts: Part A and Part B.
The study will include a screening period of 28 days for both Part A and Part B.
Part A will be a 3-period (Periods 1, 2, 3), 3-treatment (Treatments A, B, C) crossover study, performed at a single clinical unit. During the 3 periods (Periods 1, 2, 3) participants will participate from Day -1 of Period 1 to 72 hours after the nintedanib dose in Period 3. In each period, the participants will receive AZD5055 immediately before the nintedanib dose in the morning of the first day. In Part A, all participants will be randomised to one of 3 sequences.
An interim analysis of data from Part A will be performed, and Part B (conducted only if an interaction between AZD5055 and nintedanib is observed in Part A) will be a 2-period (Periods 1, 2), 2-treatment (Treatments A, D) crossover study, performed at 2 clinical units. In each period, the participants in Treatment D will be dosed with AZD5055 4 hours after the nintedanib dose in the morning of the first day. In Part B, all participants will be randomised to one of 2 sequences.
For both Part A and Part B, there will be a minimum washout period of approximately 72 hours between each AZD5055 dose administration. And, a follow-up visit will be performed, at 6 ± 1 days after the last dose of nintedanib in last period.
- Conditions
- Healthy Subjects
- Being tested
- Nintedanib, AZD5055
- Keywords
- Drug-drug interaction, Idiopathic pulmonary fibrosis, Interstitial lung diseases with progressive fibrosis, Porcupine inhibitor, Pharmacokinetics
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state.
AZD5055Drug
The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | The subjects will receive Nintedanib soft capsules, fasted state. Receives: Drug: Nintedanib |
| Treatment B | Experimental | The subjects will receive dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state. Receives: Drug: Nintedanib; Drug: AZD5055 |
| Treatment C | Experimental | The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state. Receives: Drug: Nintedanib; Drug: AZD5055 |
| Treatment D | Experimental | The subjects will receive dose C of the oral suspension of AZD5055 4 hours after nintedanib in the fasted state.
Participants would remain in the fasted state until 1.5 hours after AZD5055 administration. Receives: Drug: AZD5055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma (peak) drug concentration (Cmax)
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Measured: Day 1 - 9
Area under plasma concentration time curve from zero to infinity (AUCinf)
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Measured: Day 1 - 9
Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast)
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Measured: Day 1 - 9
Secondary outcomes (7)
Cmax of AZD5055 (Part A only)
The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib will be evaluated.
Measured: Day 1-9
AUCinf of AZD5055 (Part A only)
The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib will be evaluated.
Measured: Day 1-9
AUClast of AZD5055 (Part A only)
The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib will be evaluated.
Measured: Day 1-9
Cmax of ninetedanib alone and in combination AZD5055 (Part B only)
The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours is assessed.
Measured: Day 1-6
AUCinf of ninetedanib alone and in combination AZD5055 (Part B only)
The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours is assessed.
Measured: Day 1-6
AUClast of ninetedanib alone and in combination AZD5055 (Part B only)
The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours is assessed.
Measured: Day 1-6
Number of subject with Adverse event (AE) and serious Adverse event (SAE)
The safety and tolerability following single oral doses ofAZD5055 administered with nintedanib in healthy participants will be assessed.
Measured: SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 untill follow up (Day 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start26 May 2023
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Why it stopped: The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644600
- Sponsor's protocol ID
- D8960C00003
- Other IDs
- 2022-003116-84
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual subject-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.
- ClinicalTrials.gov ID
- NCT05644600
- Acronym / sponsor ID
- D8960C00003
- Conditions
- Healthy Subjects
- Keywords
- Drug-drug interaction, Idiopathic pulmonary fibrosis, Interstitial lung diseases with progressive fibrosis, Porcupine inhibitor, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 26 May 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to quantify the effect of co-administration and staggered dosing of AZD5055 and nintedanib on exposures of nintedanib in healthy participants.
Detailed description
This study will be an open-label, randomised, crossover study in healthy participants (males and females of non-childbearing potential).
The study will comprise two parts: Part A and Part B.
The study will include a screening period of 28 days for both Part A and Part B.
Part A will be a 3-period (Periods 1, 2, 3), 3-treatment (Treatments A, B, C) crossover study, performed at a single clinical unit. During the 3 periods (Periods 1, 2, 3) participants will participate from Day -1 of Period 1 to 72 hours after the nintedanib dose in Period 3. In each period, the participants will receive AZD5055 immediately before the nintedanib dose in the morning of the first day. In Part A, all participants will be randomised to one of 3 sequences.
An interim analysis of data from Part A will be performed, and Part B (conducted only if an interaction between AZD5055 and nintedanib is observed in Part A) will be a 2-period (Periods 1, 2), 2-treatment (Treatments A, D) crossover study, performed at 2 clinical units. In each period, the participants in Treatment D will be dosed with AZD5055 4 hours after the nintedanib dose in the morning of the first day. In Part B, all participants will be randomised to one of 2 sequences.
For both Part A and Part B, there will be a minimum washout period of approximately 72 hours between each AZD5055 dose administration. And, a follow-up visit will be performed, at 6 ± 1 days after the last dose of nintedanib in last period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: NintedanibThe subjects will receive Nintedanib soft capsules, fasted state. |
| Treatment B | Experimental | Drug: Nintedanib, Drug: AZD5055The subjects will receive dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state. |
| Treatment C | Experimental | Drug: Nintedanib, Drug: AZD5055The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state. |
| Treatment D | Experimental | Drug: AZD5055The subjects will receive dose C of the oral suspension of AZD5055 4 hours after nintedanib in the fasted state. Participants would remain in the fasted state until 1.5 hours after AZD5055 administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy nonsmoking male and female (of non-childbearing potential) participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test, must not be lactating and must be of non childbearing potential.
- Male participants and their woman partners of childbearing potential must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child.
Key exclusion criteria (15 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of chronic gastrointestinal, hepatic, or renal disease, any acute disease in these organs, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP (Investigational Medicinal Product).
- Untreated TB (Tuberculosis) or a positive result for the IGRA (Interferon Gamma Release Assay) (ie, QuantiFERON TB Gold).
- Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) .
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 |
|---|---|---|
| NintedanibThe subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state. | Drug | Treatment A, Treatment B, Treatment C |
| AZD5055The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state. | Drug | Treatment B, Treatment C, Treatment D |
Primary outcome
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1 - 9
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1 - 9
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast)
Time frame: Day 1 - 9
The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 will be assessed.
7 secondary outcomes
Cmax of AZD5055 (Part A only)
Time frame: Day 1-9
AUCinf of AZD5055 (Part A only)
Time frame: Day 1-9
AUClast of AZD5055 (Part A only)
Time frame: Day 1-9
Cmax of ninetedanib alone and in combination AZD5055 (Part B only)
Time frame: Day 1-6
AUCinf of ninetedanib alone and in combination AZD5055 (Part B only)
Time frame: Day 1-6
AUClast of ninetedanib alone and in combination AZD5055 (Part B only)
Time frame: Day 1-6
Number of subject with Adverse event (AE) and serious Adverse event (SAE)
Time frame: SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 untill follow up (Day 13)
Results and safety
The study was stopped early (reason given: The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual subject-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nintedanib and AZD5055 in people with Healthy Subjects, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. 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: stopped early, as of the sponsor's last update on 8 Feb 2024. 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 United Kingdom. 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?
The study was stopped early (reason given: The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.). Results are not available in the source record.
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 (peak) drug concentration (Cmax) (time frame: Day 1 - 9). 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?
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 8 Feb 2024.