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Trial registered on ANZCTR


Registration number
ACTRN12610001080011
Ethics application status
Approved
Date submitted
3/12/2010
Date registered
8/12/2010
Date last updated
24/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open-labeled, randomized, crossover, single-dose study in healthy male subjects to test the pharmacokinetics (how your body handles the drug e.g. how it absorbs it and how it eliminates it), safety, and tolerability of investigational drugs taken as single agents or as combinations of two investigational drugs, with a pharmacokinetics comparison to the marketed drug Reyataz(Registered Trademark)
Scientific title
An open-labeled, randomized, crossover, single-dose study in healthy male Participants to evaluate the pharmacokinetics, safety, and tolerability of stable isotopologs of atazanavir (ATV), administered as single agents or as combinations of two isotopologs, with a pharmacokinetic comparison to Reyataz(Registered Trademark)
Secondary ID [1] 253236 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
treatment and prevention of HIV 258767 0
Condition category
Condition code
Infection 258912 258912 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A participants are permitted to participate in Part B of the study. Their participation is dependant upon availablility. Part A is divided into 3 periods. Each period is separated by a 7 day washout period. 16 Subjects are divided in to Group A1 and A2. Within each group 8 subjects will be randomised to recieve one of the following treatments. Group A1 the 8 subjects are separated into 2 groups of 4. For Period 1, 8 subjects receive C-10276 200mg. For Period 2, 4 subjects will receive C-10276 400mg and 4 subjects will receive Reyataz 400mg. For Period 3 the treatment will crossover and the 4 subjects receiving C-10276 400mg in Period 2 will receive Reyataz 400mg and the 4 subjects receiving Reyataz 400 mg in Period 2 will recieve C-10276 400mg. Group A2 the 8 subjects are separated into 2 groups of 4. For Period 1 8 subjects receive C-10276 300mg. For Period 2, 4 subjects will receive C-10276 400mg and 4 subjects will receive Co-Dose Ratio 1 CTP-518 (100mg): C-10276 (300mg). For Period 3 the treatment will crossover and the 4 subjects receiving C-10276 400mg in Period 2 will receive Co-dose ratio 1 and the 4 subjects receiving Co-dose ratio 1 in Period 2 will recieve C-10276 400mg. Part B is divided in to two sub-parts. The first sub-part consists of two Groups B1 and B2, each group consists of 4 subjects. 4 subjects will receive C-10297 (200 mg) and 4 subjects will receive C-10299 (200 mg). The second sub-part will consist of three groups, B3, B4 and B5. Each group will consist of 8 subjects. These subjects will be dosed over 3 periods. Each period is separated by a 7 day washout period. For Period 1, 8 subjects will receive C-10297 (400 mg), 8 subjects will receive C-10299 (400 mg) and 8 subjects will receive C-10276 (600 mg). For Period 2, all 3 groups of 8 subjects will receive Reyataz (400 mg). For Period 3, 8 subjects will receive C-10297 (600 mg), 8 subjects will receive C-10299 (600 mg) and 8 subjects will receive Reyataz (600 mg). All the Isotopologs will be administered via oral suspension. Reyataz will be administered via oral capsules.
Intervention code [1] 257705 0
Treatment: Drugs
Intervention code [2] 257716 0
Prevention
Comparator / control treatment
Reyataz (Registered Trademark) (Atazanavir sulphate) – single oral dose 400mg (two 200 mg capsules) and single oral dose 600 mg (two 300 mg capsules)
Control group
Active

Outcomes
Primary outcome [1] 259771 0
To determine the pharmacokinetic (PK) properties, in healthy male subjects in a fed state, of single oral doses of single-agent Atazanavir (ATV) isotopologs or as combinations of two ATV isotopologs. In Part A, each group will have, 54 PK blood samples collected over the 3 treatment periods for each subject. In Part B, Group B1 and B2 will have 18 PK blood samples collected over the treatment period for each subject. Group B3, B4 and B5 will have 54 PK blood samples collected over the 3 treatment periods for each subject. PK samples for Part A and Part B will be sent to the analytical lab ofr analysis. This data will be reviewed at the end of Period 1 and at the end of Part A of the study. For Part B, the PK data will be reviewed following dosing for Group B1 and B2. For Group B3, B4 and B5, the data will be reviewed at the end of Period 1 and at the end of Part B of the study.
Timepoint [1] 259771 0
Predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours post-dose.
Secondary outcome [1] 268546 0
To compare the PK properties, in healthy male subjects in a fed state, of single oral doses of singleagent ATV isotopologs or as combinations of two ATV isotopologs with the PK properties in the same subjects, in a fed state, of a single 400 mg dose of Reyataz or a single 400 mg dose of C-10276 (Part A). In Part A, each group will have, 54 PK blood samples collected over the 3 treatment periods for each subject. In Part B, Group B1 and B2 will have 18 PK blood samples collected over the treatment period for each subject. Group B3, B4 and B5 will have 54 PK blood samples collected over the 3 treatment periods for each subject. PK samples for Part A and Part B will be sent to the analytical lab ofr analysis. This data will be reviewed at the end of Period 1 and at the end of Part A of the study. For Part B, the PK data will be reviewed following dosing for Group B1 and B2. For Group B3, B4 and B5, the data will be reviewed at the end of Period 1 and at the end of Part B of the study.
Timepoint [1] 268546 0
Days -1-3, 7-10, 7 - 14 (Follow-up, Group B1 and B2) 14-17 and 22-29 (Follow-up Part A and Group B3, B4 and B5)
Secondary outcome [2] 268571 0
To evaluate the safety and tolerability, in healthy male subjects in a fed state, of single oral doses of single-agent ATV isotopologs and as combinations of two ATV isotopologs.
To assess the safety and tolerability of the study, the Clinical laboratory results, Adverse Events, ECGs and Vital Signs taken and reviewed over the three treatment periods by a medical officer.
Timepoint [2] 268571 0
Days -1-3, 7-10, 7 - 14 (Follow-up, Group B1 and B2) 14-17 and 22-29 (Follow-up Part A and Group B3, B4 and B5)

Eligibility
Key inclusion criteria
1. Healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
2. Healthy adult males between 18 and 50 years of age, inclusive
3. Body weight greater than or equal to 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening
4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol
5. Negative tests for selected drugs of abuse, cotinine, and alcohol at screening and Day -1
6. Dietary habits that fall within the range of normal, as determined by the investigator. Examples of unusual diets are liquid diets, protein-only diets, high fat-diets, or lowcarbohydrate diets.
8. Willingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness of male subjects to use a condom and spermicide, in addition to having the female partner use another form of contraception such as an intrauterine device, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation. This criterion must be followed from the time of first study drug administration until 30 days after the final administration of study drug.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
2. PR interval = 220 msec or QRS duration = 120 msec or QT interval > 450 msec obtained at screening visit or prior to the first dose of study drug
3. Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), serum creatinine, or bilirubin > upper limit of normal (ULN) at screening or prior to the first dose of study drug.
4. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
5. Urinalysis positive for protein or glucose (greater than trace findings of protein or glucose) at screening or prior to the first dose of study drug
6. History of drug abuse within 6 months of screening
7. History of any tobacco product use within 3 months prior to the study,
8. Participation in a clinical trial and receipt of an investigational medication or a new chemical entity within 30 days, 5 half-lives, or twice the duration of the biological effect of any medication (whichever is longer) prior to the first dose of current study drug
9. Use of prescription or non-prescription medications, including herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or use of St. John’s Wort within 14 days prior to the first dose of study drug.
10. Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, or red wine within 7 days prior to administration of study drug
11. Consumption of any caffeine and/or xanthine products (ie, coffee, tea, chocolate and caffeine containing sodas, colas, etc) within 48 hours prior to each dose of study drug and while confined at the clinical site
12. Donation of blood or blood products or blood collection in excess of 470 mL within 8 weeks prior to dosing
13. History of sensitivity to any of the study drugs or components thereof, or a history of medication allergy or other allergy that, in the opinion of the investigator, contraindicates study participation
14. Unwillingness to comply with protocol-specified lifestyle and/or dietary restrictions
15. Major surgery within 4 weeks of screening
16. Uncontrolled intercurrent illness (ie, active infection)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Part A - Period 1: same treatment Period 2 &3: balanced two-way cross-over

Part B - First subpart low dose of two treatments. Second subpart: Period 1 same treatment at different dose levels, Period 2 same treatment and Period 3 partial crossover
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258173 0
Commercial sector/Industry
Name [1] 258173 0
Concert Pharmaceuticals, Inc
Country [1] 258173 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Concert Pharmaceuticals, Inc
Address
99 Hayden Avenue,
Suite 500
Lexington, MA, USA 02421
Country
United States of America
Secondary sponsor category [1] 257347 0
None
Name [1] 257347 0
Address [1] 257347 0
Country [1] 257347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260162 0
Bellberry Limited
Ethics committee address [1] 260162 0
Ethics committee country [1] 260162 0
Australia
Date submitted for ethics approval [1] 260162 0
13/10/2010
Approval date [1] 260162 0
29/11/2010
Ethics approval number [1] 260162 0
2010-10-515

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31986 0
Address 31986 0
Country 31986 0
Phone 31986 0
Fax 31986 0
Email 31986 0
Contact person for public queries
Name 15233 0
Samantha Woolman
Address 15233 0
CPR Pharma Services Pty Ltd
Suite C
32 West Thebarton Rd
THEBARTON SA 5031
Country 15233 0
Australia
Phone 15233 0
+61 8 8125 1913
Fax 15233 0
+61 8 8354 3146
Email 15233 0
Samantha.Woolman@cprservices.com.au
Contact person for scientific queries
Name 6161 0
Ginny Braman
Address 6161 0
Concert Pharmaceuticals, Inc
99 Hayden Avenue,
Suite 500
Lexington, MA, USA 02421
Country 6161 0
United States of America
Phone 6161 0
+1 781 674 5253
Fax 6161 0
+1 781-674-5353
Email 6161 0
GBraman@concertpharma.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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