A Study to Investigate the Effect of AZD5004 on Rosuvasta... | NCT06948747

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A	Experimental	Participants will receive 10 mg rosuvastatin in Period 1. Participants will receive 10 mg rosuvastatin and AZD5004 in Period 2. Later, participants will receive different doses of AZD5004 followed by 10 mg single dose of rosuvastatin in Period 3, Period 4, Period 5, and Period 6. In Period 7, participants will receive AZD5004 alone and later, 500 mg erythromycin twice a day. Participants will receive 500 mg erythromycin co-administered with AZD5004 during Period 8.	Drug: AZD5004 Drug: Rosuvastatin Drug: Erythromycin
Part B	Experimental	Participants will receive 20 mg simvastatin during Period 1. In Period 2, participants will receive 40mg atorvastatin. In Period 3, participants will receive 40 mg atorvastatin and then, AZD5004 once daily . During Period 4, participants will receive 40 mg atorvastatin with single dose of AZD5004 and later, two different doses of AZD5004 alone will be administered once a day. In Period 5, participants will receive 20 mg simvastatin with single dose of AZD5004, later, AZD5004 alone will be administered once a day. During Period 6, participants will receive 40 mg atorvastatin with single dose of AZD5004 initially, and later AZD5004 will be administered once daily. In Period 7, participants will receive AZD5004 followed by 40 mg single dose of atorvastatin.	Drug: AZD5004 Drug: Atorvastatin Drug: Simvastatin
Part C	Experimental	Participants will receive 0.5 mg repaglinide initially during Period 1, later AZD5004 once daily will be administered . Participants will then receive 0.5 mg repaglinide with single dose of AZD5004 in Period 2, later two different doses of AZD5004 once daily will be administered. In Period 3, participants will receive 0.5 mg repaglinide with single dose of AZD5004 initially, and later AZD5004 once daily will be administered. In Period 4, participants will receive 0.5 mg repaglinide with single dose of AZD5004.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD5004	Drug	Participants will receive oral tablets of AZD5004 as single dose on the following days, (i) Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 and Day 55 in Part A. (ii) Day 9 to Day15, Day 16, Day 17 to Day 23, Day 24 to Day 30, Day 31 to Day 37, Day 38 to Day 41 and Day 42 in Part B. (iii) Day 3 to Day 9, Day 10 to Day 25, Day 26 to Day 33, and Day 34 in Part C.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A, Part B and Part C: Area under concentration time curve from time 0 to infinity (AUCinf)	Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants. Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants. Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.	Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36
Part A, Part B and Part C: Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)	Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants. Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants. Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.	Part A:Days 1-4, 7-10, 14-17, 21-24, 28-31, 35-38, 42-49 and 55-62 Part B:Days 1, 2, 4-7, 8-11, 15, 16-19, 23, 24, 30, 31, 32, 37, 38-41, 42-45 Part C:Days 1, 2, 9, 10, 11, 18, 19, 25, 26, 27, 33, 34-36
Part A, Part B and Part C: Maximum observed drug concentration (Cmax)	Part A: To assess the effect of single dose of AZD5004 on the PK of a single dose of rosuvastatin and multiple doses of erythromycin on the PK of a single dose of AZD5004 in healthy participants. Part B: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of atorvastatin and atorvastatin metabolites (o-hydroxy atorvastatin and p-hydroxy atorvastatin) and simvastatin and simvastatin metabolites (simvastatin acid) in healthy participants. Part C: To assess the effect of multiple doses of AZD5004 on the PK of a single dose of repaglinide in healthy participants.

Secondary Outcomes

Measure	Description	Time Frame
Part A, Part B and Part C: Number of participants with adverse events (AEs) and adverse event of special interest (AESI)	To examine the safety and tolerability of AZD5004 alone and in combination with, the following drugs in healthy participants as listed below Part A: rosuvastatin or erythromycin Part B: atorvastatin and simvastatin Part C: repaglinide	Part A: From screening (Day -28 to -2 ) to followup visit (Day 65) Part B: From screening (Day -28 to -2) to followup visit (Day 48) Part C: From screening (Day -28 to -2) to followup visit (Day 38)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female participants aged 18 to 55 years
All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
Female(s) of childbearing potential if heterosexually active, must agree to use an approved method of highly effective contraception.
Male participants must use condoms for the duration of clinical trial.
Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial.
Have a body mass index (BMI) between ≥ 20.0 and ≤ 35 kg/m2 (at the time of screening) inclusive and weigh at least 50 kg.

Exclusion Criteria:

History of any clinically important disease or disorder (liver transplant, liver disease, positive for serum HBsAg (Hepatitis B surface antigen) OR anti-HBcAb (Hepatitis B core antibody), positive for anti-HCV (Hepatitis C virus), history of cirrhosis and/or hepatic decompensation, cardiovascular disease, neuromuscular or neurogenic disease.
History of Type 1 or Type 2 diabetes mellitus (DM).
History of Hemoglobin A1c ≥ 6.5% (≥ 48 mmol/mol) at screening.
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important illness, medical/surgical procedure, or trauma.
Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis at the Screening Visit or on admission to the Clinical Unit.
Significant hepatic disease as judged by the investigator.
Any positive result on screening for serum HBsAg, HBcAb or HIV (Human immunodeficiency virus).
Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead ECG, at screening
Abnormal vital signs.
Uncontrolled thyroid disease or history/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
Current smokers or those who have smoked or used nicotine products.
Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for females.
Positive screen for drugs of abuse, or alcohol or cotinine at screening or on each admission to the Clinical Unit.
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
Excessive intake of caffeine-containing drinks or food
History of psychosis or bipolar disorder or major depressive disorder or suicide attempt or suicidal ideation.

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Brooklyn	Maryland	21225	United States

IPD Sharing Statement Module

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000068718	Rosuvastatin Calcium
D004917	Erythromycin
D000069059	Atorvastatin
D019821	Simvastatin
C072379	repaglinide

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D011758	Pyrroles
D001393	Azoles
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D011083	Polycyclic Compounds