Trial Outcomes & Findings for Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy (NCT NCT05605301)
NCT ID: NCT05605301
Last Updated: 2026-06-09
Results Overview
Area under the concentration-time curve from time zero to the last measurable concentration for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
From time of drug administration until 24 hours post-dose
Results posted on
2026-06-09
Participant Flow
Participants with a confirmed diagnosis of epilepsy were recruited and enrolled at the University of Virginia between September 2, 2022 and February 5, 2024. All participants were screened for eligibility and enrolled into sequential dosing cohorts.
Participant milestones
| Measure |
2DG 40 mg Single Dose
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
Baseline characteristics by cohort
| Measure |
2DG 40 mg Single Dose
n=3 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=3 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=3 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35 years
n=20 Participants
|
31 years
n=20 Participants
|
31 years
n=40 Participants
|
32 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Area under the concentration-time curve from time zero to the last measurable concentration for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=3 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=3 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=3 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Observed Time Point (AUClast)
|
2.81 hour*ug/mL
Standard Deviation 0.49
|
2.93 hour*ug/mL
Standard Deviation 1.13
|
4.16 hour*ug/mL
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Area under the concentration-time curve from time zero extrapolated to infinity for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=1 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=2 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=2 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf)
|
3.56 hr*ug/mL
Standard Deviation NA
Standard deviation could not be calculated because only one participant had a determinable AUCinf value in this arm.
|
3.19 hr*ug/mL
Standard Deviation 1.59
|
4.71 hr*ug/mL
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Elimination half-life (t1/2) of 2-deoxy-D-glucose (2DG), estimated from the terminal phase of the concentration-time curve following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=1 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=2 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=2 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Elimination Half-Life (t1/2)
|
1.58 hr
Standard Deviation NA
Standard deviation could not be calculated because only one participant had a determinable half-life value in this arm.
|
0.968 hr
Standard Deviation 0.25
|
1.47 hr
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Elimination rate constant (Kel) of 2-deoxy-D-glucose (2DG), estimated from the terminal phase of the concentration-time curve following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=1 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=2 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=2 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Elimination Rate Constant (Kel)
|
0.439 1/hr
Standard Deviation NA
Standard deviation could not be calculated because only one participant had a determinable elimination rate constant value in this arm.
|
.741 1/hr
Standard Deviation 0.19
|
.475 1/hr
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Time of the last observed measurable concentration of 2-deoxy-D-glucose (2DG) following dosing, calculated from blood samples collected at predefined time points. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=3 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=3 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=3 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Time of Last Observed Concentration (Tlast)
|
6.00 hr
Standard Deviation 0.00
|
4.67 hr
Standard Deviation 1.16
|
6.00 hr
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Time to maximum observed blood concentration of 2-deoxy-D-glucose (2DG) following dosing, calculated from blood samples collected at predefined time points. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=3 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=3 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=3 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Time to Maximum Observed Blood Concentration (Tmax)
|
1.58 hr
Standard Deviation 0.73
|
0.833 hr
Standard Deviation 0.14
|
2.00 hr
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: From time of drug administration until 24 hours post-dosePopulation: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.
Maximum observed blood concentration of 2-deoxy-D-glucose (2DG) following dosing, calculated from blood samples collected at predefined time points. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Outcome measures
| Measure |
2DG 40 mg Single Dose
n=3 Participants
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=3 Participants
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=3 Participants
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Maximum Observed Blood Concentration (Cmax)
|
1.26 ug/mL
Standard Deviation 0.31
|
1.68 ug/mL
Standard Deviation 0.54
|
1.54 ug/mL
Standard Deviation 0.45
|
Adverse Events
2DG 40 mg Single Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
2DG 60 mg Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2DG 60 mg Twice Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2DG 40 mg Single Dose
n=3 participants at risk
Participants received a single oral dose of 40 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Single Dose
n=3 participants at risk
Participants received a single oral dose of 60 mg 2-deoxy-D-glucose (2DG) and underwent pharmacokinetic and safety monitoring for up to 24 hours post-dose.
|
2DG 60 mg Twice Daily
n=3 participants at risk
Participants received two oral doses of 60 mg 2-deoxy-D-glucose (2DG) administered approximately 12 hours apart and underwent pharmacokinetic and safety monitoring through 24 hours after the second dose.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
General disorders
Feeling Cold
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Eye disorders
Dry Eyes
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
|
Investigations
Left Ventricular Ejection Fraction Decrease
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
33.3%
1/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
0.00%
0/3 • From time of first dose through 14 days post-dose
Adverse events were defined and classified as serious or non-serious according to standard criteria. All participants who received study drug were included in the adverse event analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place