A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

30 May 2023 → 1 Sep 2023

Decision date (initial)

2023-04-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Bioequivalence

To assess the relative bioavailability of G004 with API with higher PSD (test) as compared to G004 with representative API (reference) at a single oral dose of 240 mg lazertinib in healthy adult participants under fasted condition. To assess the relative bioavailability of G005 with API with higher PSD (test) as compared to G005 with representative API (reference) at a single oral dose of 240 mg lazertinib in healthy adult participants under fasted condition.

Conditions and MedDRA coding

Non-small cell lung cancer (NSCLC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Healthy participants between 18 and 60 years of age, inclusive; body mass index (BMI) between 19.0 and 30.0 kg/m², inclusive, and a body weight of not less than 50.0 kg. For a full list of inclusion criteria please refer to section 5.1 of clinical protocol on pages 27-28

Exclusion criteria 1

1. History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and interstitial lung disease, diabetes mellitus (with the exception of history of gestational diabetes), hepatic insufficiency, inflammation bowel disease/Crohn’s disease, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. 2. History of confirmed COVID-19 infection within 4 weeks before first intake of study intervention; or has ongoing symptoms from COVID-19 infection at screening, or tests positive for SARS-CoV-2 at screening or at admission to the study site of each intervention period. 3. History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed). 4. History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence). 5. Known allergies, hypersensitivity, or intolerance to lazertinib or its excipients (refer to IB lazertinib 2022). 6. Participant has a history of clinically significant drug allergies (except with history of allergic rhinitis and with history of food allergies). 7 Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 8. Had major surgery (eg, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participant in the study or within 4 weeks after the last dose of study intervention. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Prior/Concomitant Therapy 9. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy before the planned first dose of study intervention. 10. Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, ibuprofen, and stable hormone replacement therapy (in postmenopausal female participants only) within 14 days before the first dose of study intervention is scheduled until completion of the study (Section 6.8, Concomitant Therapy). Prior/Concurrent Clinical Study Experience 11. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within the required washout period: If the drug’s half-life is known, 5 times the drug’s half-life, or 30 days, whichever is longer. If the drug’s half-life is unknown, 30 days for small molecules, 60 days for proteins, and 90 days for monoclonal antibodies. Diagnostic Assessments 12 Positive test for hepatitis A IgM (exemption of hepatitis A vaccination), hepatitis B, (i.e., HBsAg or anti-HBc positive and anti-HBs negative [See Section 10.6, Appendix 6: Hepatitis B Virus (HBV) Screening]) or HCV antibodies (anti-HCV) at screening. Hepatitis B surface antibody positivity is not exclusionary in context of previous hepatitis B vaccination. 13. History of HIV antibody positive, or tests positive for HIV at screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pharmacokinetic parameters for the reference and test interventions: Cmax, AUC0-72h.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 4

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications