Pain Management
Conditions
Brief summary
This is a single-center, open-label, part-randomized, crossover study in 14 healthy participants to assess the PK and safety profile of an SDD formulation of LTG-001 and two crystalline LTG-001 Instant Release tablet formulations, one of which will also be assessed at a differing dose level.
Interventions
DRUGLTG-001 SDD
LTG-001
DRUGLTG-001 Formulation A Prototype 1
LTG-001
DRUGLTG-001 Formulation B Prototype 2
LTG-001
DRUGLTG-001 Formulation B prototype 2
LTG-001 High Dose
Sponsors
Latigo Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. * Must be willing and able to comply with all study requirements Aged 18 to 55 years inclusive at the time of signing informed consent. * Must agree to use an adequate method of contraception (as defined in Section 9.4. * Healthy males or non-pregnant, non-lactating, healthy females. * Body mass index of 18.0 to 32.0 kg/m2 as measured at screening. * Weight ≥50 kg at screening.
Exclusion criteria
* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients. * Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. * Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria. * History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, as judged by the investigator. * Have poor venous access that limits phlebotomy. * Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Participants with Gilbert's Syndrome are allowed. * Has ALT or AST \>1.5 × ULN; Total bilirubin \>1.5 × ULN (for participants with known Gilbert's syndrome these criteria only apply if the total bilirubin \>1.5 × ULN as long as direct bilirubin is ≤1.5 × ULN) at screening. * Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<90 mL/min using the Cockcroft-Gault equation * Positive HBsAg, HCV Ab or HIV antibody results at screening. * Positive serum pregnancy test at screening or positive urine pregnancy test at first * Participants who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days. * Participants who report to have previously received LTG-001. admission. Those who are pregnant or lactating will be excluded. * Personal or family history of long QT syndrome or a QTcF interval \> 450 msec for men or \> 470 for women on screening or first admission ECG. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or oral contraception) in the 14 days before IMP administration (see Section 11.4). Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the investigator. * Participants who have had any vaccine within 15 days before first IMP administration History of any drug or alcohol abuse in the past 2 years. * Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine). * A confirmed positive alcohol urine test at screening or first admission. * Current smokers and those who have smoked within the last 12 months. * Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months. * A confirmed positive urine cotinine test at screening or first admission. * Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1) Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication. * Participants who are, or are immediate family members of, a study site or sponsor employee. * Failure to satisfy the investigator of fitness to participate for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state. | From enrollment to Period 4, Day 3 Discharge | results of LTG001 peak plasma concentration (Cmax) |
| Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state | from enrollment to Period 4, Day 3 discharge | Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-last)) |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state. | From Enrollment to Period 4, Day 3 discharge | Results of Cmax |
| To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state | From enrollment to period 4, Day 3 Discharge | Results of Tmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective | from enrollment to Follow up phone call | To assess safety and tolerability of single doses of LTG-001 when administered as IR formulations by evaluating number of participants with adverse events and SAEs, with abnormal laboratory tests results, abnormal 12-lead ECG readings, abnormal vital sign measurements and abnormal physical examination findings |
Countries
United States
Outcome results
None listed