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Intervention Sequence: DCAB for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre dose up to 168 hours post dose
Awards & highlights

Study Summary

This trial tests if 4 versions of a medicine are the same in healthy adults when taken on an empty stomach.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre dose up to 168 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre dose up to 168 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interventions A, B and C: Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) of Lazertinib
Interventions A, B and C: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
Secondary outcome measures
Interventions A and D: Area Under the Plasma Concentration-time Curve from Time of 0 to 72 Hours [AUC (0-72h)] of Lazertinib
Interventions A and D: Maximum Observed Plasma Concentration (Cmax) of Lazertinib
Number of Participants With AEs by Severity
+6 more

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT04075396
47%
Anaemia
47%
Diarrhoea
27%
Dyspnoea
27%
Nausea
27%
Aspartate Aminotransferase Increased
27%
Rash
20%
Hyperkalaemia
20%
Blood Alkaline Phosphatase Increased
20%
Dizziness
20%
Neutrophil Count Decreased
20%
Asthenia
20%
Alanine Aminotransferase Increased
20%
Hyponatraemia
20%
Oedema Peripheral
20%
Pain in Extremity
20%
Back Pain
20%
Paronychia
13%
Pain
13%
Decreased Appetite
13%
Hypercholesterolaemia
13%
Neutropenia
13%
Pulmonary Embolism
13%
Abdominal Pain Upper
13%
Vomiting
13%
Blood Creatinine Increased
13%
Hypermagnesaemia
13%
Paraesthesia
13%
Cough
13%
Hypercalcaemia
13%
Muscular Weakness
13%
Arthralgia
7%
Cancer Pain
7%
Medical Device Pain
7%
Bronchitis
7%
Bone Pain
7%
Chest Pain
7%
Onychoclasis
7%
Dysphagia
7%
Deep Vein Thrombosis
7%
Dry Mouth
7%
Neurotoxicity
7%
Benign Prostatic Hyperplasia
7%
Dyspepsia
7%
Appetite Disorder
7%
Angina Pectoris
7%
Vertigo Positional
7%
Musculoskeletal Chest Pain
7%
Adrenalectomy
7%
Vision Blurred
7%
Covid-19
7%
Hordeolum
7%
Pathological Fracture
7%
Leukopenia
7%
Gingival Pain
7%
Abdominal Pain
7%
Cerebrovascular Accident
7%
Onychomadesis
7%
Lymphopenia
7%
Pneumonia
7%
Thrombocytopenia
7%
Constipation
7%
Disorientation
7%
Fatigue
7%
White Blood Cell Count Decreased
7%
Induration
7%
Gait Disturbance
7%
Polydipsia
7%
Headache
7%
Tremor
7%
Folliculitis
7%
Skin Lesion
7%
Weight Decreased
7%
Conjunctivitis
7%
Blood Magnesium Decreased
7%
Troponin I Increased
7%
Dysarthria
7%
Pleural Effusion
7%
Blood Sodium Decreased
7%
Chromaturia
7%
Skin Hyperpigmentation
7%
Pruritus
7%
Blood Bilirubin Increased
7%
Rash Maculo-Papular
7%
Dermatitis Acneiform
7%
Troponin Increased
7%
Polyuria
7%
Rash Macular
7%
Peripheral Sensory Neuropathy
7%
Sciatica
7%
Dysuria
7%
Confusional State
7%
Epistaxis
7%
Solar Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lazertinib 240 mg
Lazertinib 320 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Intervention Sequence: DCABExperimental Treatment1 Intervention
Participants will receive intervention D (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 3 followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
Group II: Intervention Sequence: CBDAExperimental Treatment1 Intervention
Participants will receive intervention C (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
Group III: Intervention Sequence: BACDExperimental Treatment1 Intervention
Participants will receive intervention B (lazertinib test formulation) on Day 1 of intervention Period 1, followed by intervention A (lazertinib reference formulation) on Day 1 of intervention Period 2, followed by intervention C (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
Group IV: Intervention Sequence: ADBCExperimental Treatment1 Intervention
Participants will receive intervention A (lazertinib reference formulation) on Day 1 of intervention Period 1, followed by intervention D (lazertinib test formulation) on Day 1 of intervention Period 2, followed by intervention B (lazertinib test formulation) on Day 1 of intervention Period 3 followed by intervention C (lazertinib test formulation) on Day 1 of Intervention Period 4. There will be a wash-out period of at least 14 days and up to 21 days between each intervention period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lazertinib
2021
Completed Phase 2
~770

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,244 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrailStudy DirectorJanssen Research & Development, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How detrimental is Intervention Sequence: ADBC to those undergoing the treatment?

"As Intervention Sequence: ADBC is a Phase 1 trial, with limited clinical data for safety and effectiveness, it has been assigned an initial score of one."

Answered by AI

What is the current number of volunteers for this clinical research?

"Affirmative. Clinicaltrials.gov confirms that this study, which was initially posted on March 1st 2023, is currently recruiting candidates. In total, 64 participants are required from a single trial site."

Answered by AI

Is the enrollment age limit below 75 years old for this clinical experiment?

"This clinical trial is seeking individuals aged between 18 and 55 years old. For those below the age of consent, there are 48 trials available to them and 366 for seniors above 65."

Answered by AI

Has enrollment commenced for this investigation?

"That is correct. Clinicaltrials.gov offers confirmation that the trial, which was initially listed on January 3rd 2023, is presently recruiting individuals for enrollment. 64 participants are needed from 1 medical centre."

Answered by AI

To whom is enrollment into this clinical study available?

"This clinical trial is currently recruiting 64 volunteers, aged 18 to 55, with the health status of a healthy individual. They must also fulfill additional requirements such as passing physical examination and medical history reviews prior to enrollment. Additionally, female participants need to have negative Beta-HCG results while male candidates should abstain from donating sperm for 6 months following their last dose in this study. All participants are expected sign an Informed Consent Form (ICF) that they understand the purpose and procedure during the study period prior to joining it."

Answered by AI

What are the ultimate goals of this experiment?

"The primary objective of this medical trial, to be assessed over a 168 hour period beginning with pre-dose measurements, is determining the Area Under the Plasma Concentration-time Curve from Time 0 to 72 Hours (h) (AUC[0-72h]) for Lazertinib in Interventions A, B and C. Other outcomes include further analysis of AUC(0-72h) related to interventions A and D; Number of Participants With Adverse Events (AEs); and Number of Participants With Serious Adverse Events (SAEs)."

Answered by AI
~28 spots leftby Apr 2025